Johnson & Johnson Professionals, Inc.
Raynham, MA, US
Johnson & Johnson Professionals, Inc. appears in FDA device records in Raynham, MA. FDA records list 206 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 206
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 206FDA records hold 206 510(k) clearances for Johnson & Johnson Professionals, Inc. between 1976 and 2000. The busiest year on record is 1977, with 17. The most recent is 2000, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 17 |
| 1978 | 8 |
| 1979 | 8 |
| 1980 | 8 |
| 1981 | 14 |
| 1982 | 10 |
| 1983 | 17 |
| 1984 | 10 |
| 1985 | 14 |
| 1986 | 17 |
| 1987 | 12 |
| 1988 | 3 |
| 1989 | 6 |
| 1990 | 1 |
| 1994 | 5 |
| 1995 | 13 |
| 1996 | 16 |
| 1997 | 9 |
| 1998 | 11 |
| 1999 | 1 |
| 2000 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992173 | SIPHONGUARD CSF CONTROL DEVICE | JXG | Substantially Equivalent | |
| K991413 | CODMAN ETHISORB DURA PATCH | GXQ | Substantially Equivalent | |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | GWM | Substantially Equivalent | |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | HCI | Substantially Equivalent | |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | KWY | Substantially Equivalent | |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | JDB | Substantially Equivalent | |
| K983014 | SUMMIT ACETABULAR SYSTEM | LPH | Substantially Equivalent | |
| K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM | JXG | Substantially Equivalent | |
| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | JXG | Substantially Equivalent | |
| K980801 | J-FX BIPOLAR HEAD | KWY | Substantially Equivalent | |
| K980081 | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD | LZO | Substantially Equivalent | |
| K980286 | ULTIMA ACETABULAR ROOF REINFORCEMENT RING | JDI | Substantially Equivalent | |
| K974331 | UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM | LPH | Substantially Equivalent | |
| K974088 | CODMAN INTRACRANIAL BOLT | GWM | Substantially Equivalent | |
| K973774 | CODMAN HAKIM MICRO PRECISION VALVE | JXG | Substantially Equivalent | |
| K973307 | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD | LZO | Substantially Equivalent for Some Indications | |
| K972435 | ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM | JDI | Substantially Equivalent | |
| K971189 | P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) | JWH | Substantially Equivalent | |
| K971652 | P.F.C. SIGMA INSET PATELLA | JWH | Substantially Equivalent | |
| K971682 | J-FX CERCLAGE SYSTEM | LRN | Substantially Equivalent | |
| K964923 | CODMAN LUMBAR DRAINAGE CATHETER KIT | JXG | Substantially Equivalent | |
| K964795 | CEMENTED CALCAR REPLACEMENT FEMORAL STEM | JDI | Substantially Equivalent | |
| K965156 | ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES | KWL | Substantially Equivalent | |
| K963885 | ULTIMA FX FEMORAL HIP STEMS | KWY | Substantially Equivalent | |
| K963117 | P.F.C. CRUCIATE RETAING KNEE SYSTEM | JWH | Substantially Equivalent | |
| K963206 | S-ROM HIP SYSTEM - LOCKING PLUG | JDI | Substantially Equivalent | |
| K954481 | P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM | HRY | Substantially Equivalent | |
| K963499 | MIRROR FINISH BIPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K962429 | SAFETY VEST | FMQ | Substantially Equivalent | |
| K962248 | P.F.C. CERAMIC HIP HEAD | LZO | Substantially Equivalent | |
| K961939 | S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115) | LPH | Substantially Equivalent | |
| K961685 | P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) | JWH | Substantially Equivalent | |
| K945518 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT | KWY | Substantially Equivalent | |
| K953202 | P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT | JDI | Substantially Equivalent for Some Indications | |
| K953200 | ULTIMA SIZE 0 CEMENTED FEMORAL STEM | JDI | Substantially Equivalent for Some Indications | |
| K952859 | ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT | JDI | Substantially Equivalent for Some Indications | |
| K955385 | JOHNSON & JOHNSON AUSTIN MOORE STEM | KWL | Substantially Equivalent | |
| K944544 | ABSORBABLE BONE SCREW | MAI | Substantially Equivalent | |
| K952830 | DARWIN KNEE SYSTEM (TC3) | JWH | Substantially Equivalent for Some Indications | |
| K954699 | BRAY RONGEUR | HAE | Substantially Equivalent | |
| K954851 | BIOPOLAR FORCEPS LINE | GEI | Substantially Equivalent | |
| K953730 | CODMAN ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent for Some Indications | |
| K945585 | COMAN(R) CU-11 MODEL NUMBER 82-6634 | GWM | Substantially Equivalent | |
| K954021 | EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) | JXG | Substantially Equivalent | |
| K944222 | CODMAN-MEDOS VALVE SHUNT SYSTEM | JXG | Substantially Equivalent | |
| K952161 | BIPOLAR COAGULATION INSTRUMENT | GEI | Substantially Equivalent | |
| K950563 | ULTIMA AUGMENTED UHMWPE CUP | KWL | Substantially Equivalent | |
| K951934 | PFC CEMENT RESTRICTOR | LZN | Substantially Equivalent for Some Indications | |
| K950010 | DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED | JWH | Substantially Equivalent for Some Indications | |
| K945793 | P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR | KWY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- EJJAlloy, Amalgam
- EJHAlloy, Metal, Base
- EJSAlloy, Other Noble Metal
- HCIApplier, Aneurysm Clip
- ITGBandage, Cast
- FQMBandage, Elastic
- DZSCapsule, Dental, Amalgam
- EMACement, Dental
- EBECoating, Denture Hydrophilic, Resin
- EBDCoating, Filling Material, Resin
- EXBCollector, Ostomy
- JECComponent, Traction, Invasive
- FLLContinuous Measurement Thermometer
- GLKControl, Hematocrit
- GWMDevice, Monitoring, Intracranial Pressure
- EHEDispenser, Mercury And/Or Alloy
- FRODressing, Wound, Drug
- GXQDura Substitute
- DXKEchocardiograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GCOEndoscope, Mirror
- GWGEndoscope, Neurological
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- EYQGarment, Protective, For Incontinence
- EFQGauze/Sponge, Internal
- GDYGauze/Sponge, Internal, X-Ray Detectable
- DXYImplantable Pacemaker Pulse-Generator
- FHXJelly, Lubricating, For Transurethral Surgical Instrument
- KDDKit, Surgical Instrument, Disposable
- EBFMaterial, Tooth Shade, Resin
- DTZOxygenator, Cardiopulmonary Bypass
- HHLPad, Menstrual, Scented, Scented-Deodorized
- HHDPad, Menstrual, Unscented
- HTYPin, Fixation, Smooth
- EKNPoint, Paper, Endodontic
- EIHPowder, Porcelain
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- FMPProtector, Skin Pressure
- DTNReservoir, Blood, Cardiopulmonary Bypass
- FMQRestraint, Protective
- HAERongeur, Manual
- EBCSealant, Pit And Fissure, And Conditioner
- JXGShunt, Central Nervous System And Components
- ILISling, Arm
- FYHSplint, Extremity, Noninflatable, External, Sterile
- FPXStrip, Adhesive, Closure, Skin
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HEBTampon, Menstrual, Unscented
- EFWToothbrush, Manual
- JOPTransducer, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain