Pfizer Inc
Parsippany, NJ, US
Pfizer Inc appears in FDA device records in Parsippany, NJ. FDA records list 30 510(k) clearances between and , 46 PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 30 510(k) clearances for Pfizer Inc between 1977 and 2018. The busiest year on record is 1985, with 13. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 1 |
| 1979 | 5 |
| 1980 | 2 |
| 1985 | 13 |
| 1986 | 1 |
| 1988 | 1 |
| 1989 | 2 |
| 1999 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181102 | ThermaCare Quick Therapy TENS | NUH | Substantially Equivalent | |
| K991620 | VISINE FOR CONTACTS | LPN | Substantially Equivalent | |
| K892264 | ORALCHEK SUPER-SOFT BRUSH | EFW | Substantially Equivalent | |
| K892360 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | FRO | Substantially Equivalent | |
| K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE | LXI | Substantially Equivalent | |
| K854726 | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP | EXB | Substantially Equivalent | |
| K850840 | HOWMEDICA THREADED ACETABULAR COMPONENT | KWA | Substantially Equivalent | |
| K850443 | MEC ROD CONNECTOR | KTT | Substantially Equivalent | |
| K850413 | MEC HIP BOLT | KTT | Substantially Equivalent | |
| K850403 | MEC DISTAL FEMORAL BOLT | KTT | Substantially Equivalent | |
| K851971 | SERIES 7000/HOLTER RECORDER | DSH | Substantially Equivalent | |
| K852041 | DEKNATEL THORACIC CATHETER | JOL | Substantially Equivalent | |
| K851024 | PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE | CAC | Substantially Equivalent | |
| K850886 | COMPRESSION HIP SCREW SYSTEM | KIT | Substantially Equivalent | |
| K850444 | MEC BUTRESS PLATE | HRS | Substantially Equivalent | |
| K850442 | MEC BROAD BONE PLATE | HRS | Substantially Equivalent | |
| K850441 | MEC INTRAMEDULLARY ROD | HSB | Substantially Equivalent | |
| K850401 | LETOURNEL ACETABULAR PLATE | HRS | Substantially Equivalent | |
| K844938 | UNITED SKIN BARRIERS | EXB | Substantially Equivalent | |
| K792349 | SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. | JNT | Substantially Equivalent | |
| K791523 | VISALENS ALL PURPOSE SOLUTION FOR LENS | HPX | Substantially Equivalent | |
| K791524 | VISALENS CONCENTRATED CLEANER CONT LENS | HPX | Substantially Equivalent | |
| K791163 | PFIZER 0200FS LOCALLZER | JAK | Substantially Equivalent | |
| K791153 | ACTA-SCANNER 0220FS | JAK | Substantially Equivalent | |
| K790089 | TAPE MEASURE | FTY | Substantially Equivalent | |
| K782086 | AM-PEN SCREEN | JTO | Substantially Equivalent | |
| K780413 | LOW IIONIC STRENGTH SOLUTION | KSG | Substantially Equivalent | |
| K772291 | DIAG. CONSOLE, INDEPENDENT | JAK | Substantially Equivalent | |
| K771620 | ALKALINE PHOSPHATASE ISOENZY. SUB. SET | CIN | Substantially Equivalent | |
| K770833 | FLUORETEC-M | GMY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004945409 | 3004945409 | Pfizer Inc | 400 Webro Road, Parsippany, NJ 07054 US | 2026 | |
| 3009712172 | 3009712172 | Pfizer Inc | 1855 N Shelby Oaks Dr, Memphis, TN 38134 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LPNAccessories, Soft Lens Products
- LMFAgent, Absorbable Hemostatic, Collagen Based
- GMYAntisera, Fluorescent, All Types, Escherichia Coli
- CACApparatus, Autotransfusion
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- JOLCatheter And Tip, Suction
- JNTChromatographic, Phospholipids
- EXBCollector, Ostomy
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- FRODressing, Wound, Drug
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- LXIGuide, Drill, Ligament
- HPXLens, Contact (Polymethylmethacrylate)
- KITMedia And Components, Synthetic Cell And Tissue Culture
- KSGMedia, Potentiating For In Vitro Diagnostic Use
- OUGMedical Device Data System
- HRSPlate, Fixation, Bone
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- DSHRecorder, Magnetic Tape, Medical
- HSBRod, Fixation, Intramedullary And Accessories
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- JTTSusceptibility Test Powders, Antimicrobial
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- JAKSystem, X-Ray, Tomography, Computed
- FTYTape, Measuring, Rulers And Calipers
- EFWToothbrush, Manual
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0556-2019 | Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis. | The firm received complaints of the wrap coming apart and leaking granular material | Class II | Terminated | |
| Z-0555-2019 | Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches. | The firm received complaints of the wrap coming apart and leaking granular material | Class II | Terminated | |
| Z-0554-2019 | Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis. | The firm received complaints of the wrap coming apart and leaking granular material | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain