Tecnol New Jersey Wound Care, Inc.
Hammonton, NJ, US
Tecnol New Jersey Wound Care, Inc. appears in FDA device records in Hammonton, NJ. FDA records list 35 510(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
- 35
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 35 510(k) clearances for Tecnol New Jersey Wound Care, Inc. between 1976 and 1991. The busiest year on record is 1976, with 5. The most recent is 1991, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 5 |
| 1977 | 1 |
| 1979 | 2 |
| 1980 | 2 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1986 | 1 |
| 1987 | 5 |
| 1988 | 5 |
| 1989 | 5 |
| 1990 | 1 |
| 1991 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K913043 | MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS | FXX | Substantially Equivalent | |
| K911891 | FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK | FXX | Substantially Equivalent | |
| K911907 | FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS | FXX | Substantially Equivalent | |
| K896193 | TECNOL LAZER(TM) SURGICAL MASK | FXX | Substantially Equivalent | |
| K894205 | TECNOL SILK STRIP | FPX | Substantially Equivalent | |
| K893702 | TECNOL GAITERS PRODUCT NUMBER 47725-010 | FXP | Substantially Equivalent | |
| K891187 | TECNOL NASO-GASTRIC TUBE HOLDER | BSS | Substantially Equivalent | |
| K891178 | TECNOL SECURE-ALL TUBE HOLDER | EYZ | Substantially Equivalent | |
| K884440 | TECNOL VARIABLE TENSION BANDAGE | NAD | Substantially Equivalent for Some Indications | |
| K882640 | TECNOL SECURE-ALL PELVIC TRACTION BELT | KQZ | Substantially Equivalent | |
| K882641 | TECNOL CATHETER LEG STRAP | KNY | Substantially Equivalent | |
| K882128 | TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 | FXP | Substantially Equivalent | |
| K874894 | TECNOL LASER SURGICAL MASK | FXX | Substantially Equivalent | |
| K880757 | TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD | FXX | Substantially Equivalent | |
| K873368 | TECNOL COMPRESSION KNEE DRESSING | LLK | Substantially Equivalent | |
| K874608 | TECNOL FLUID SHIELD SURGICAL MASK | FXX | Substantially Equivalent | |
| K873785 | TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE | FXX | Substantially Equivalent | |
| K873830 | TECNOL SURGEON'S CAP | FYF | Substantially Equivalent | |
| K870056 | TECNOL CLASSIC CONE MASK | FXX | Substantially Equivalent | |
| K861189 | TECNOL SECURE-ALL FETAL MONITOR STRAP | HGM | Substantially Equivalent | |
| K831148 | HIGH FILTRATION ISO-MASK | FXX | Substantially Equivalent | |
| K832194 | SURGICAL FACE MASK-DISPOSABLE | FXX | Substantially Equivalent | |
| K831149 | PERSONAL KNEE CRUTCH PAD | INP | Substantially Equivalent | |
| K813030 | O.R. ARMBOARD COVER | FWZ | Substantially Equivalent | |
| K802850 | TECNOL O.R. TOURNIQUET COVER | EYR | Substantially Equivalent | |
| K802849 | TECNOL TELEMETRY UNIT POUCH | DRG | Substantially Equivalent | |
| K801272 | TECNOL QUICK RELEASE LIMB HOLDER | FMQ | Substantially Equivalent | |
| K791859 | TECNOL STIRRUPS STRAP | BWN | Substantially Equivalent | |
| K790699 | TECNOL BODY HOLDER | FMQ | Substantially Equivalent | |
| K770635 | PROTECTOR, HEEL & ELBOW | FMP | Substantially Equivalent | |
| K760782 | TECNOL PATIENT USE ICE PACK | ILO | Substantially Equivalent | |
| K760772 | DISPOSABLE ABDOMINAL BINDER | FSD | Substantially Equivalent | |
| K760308 | I.V. SUPPORT, TECNOL ARMBOARD | FSE | Substantially Equivalent | |
| K760307 | BEDPAN, SINGLE PATIENT USE, TECNOL | FOB | Substantially Equivalent | |
| K760309 | LIMB HOLDER, TECNOL REMINDER | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- FOBBedpan
- FSDBinder, Abdominal
- FYFCap, Surgical
- KQZComponent, Traction, Non-Invasive
- FXPCover, Shoe, Operating-Room
- NADDressing, Wound, Occlusive
- LLKLegging, Compression, Non-Inflatable
- FXXMask, Surgical
- FWZOperating Room Accessories Table Tray
- ILOPack, Hot Or Cold, Water Circulating
- FMPProtector, Skin Pressure
- FMQRestraint, Protective
- FPXStrip, Adhesive, Closure, Skin
- HGMSystem, Monitoring, Perinatal
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- BWNTable And Attachments, Operating-Room
- FSETable, Operating-Room, Manual
- INPTips And Pads, Cane, Crutch And Walker
- EYRTourniquet, Gastro-Urology
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- BSSTube, Nasogastric
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