Company ยท US
Pfizer, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2018. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 3 |
| IMD | Pack, Hot Or Cold, Disposable | 3 |
| JAK | System, X-Ray, Tomography, Computed | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 |
| EXB | Collector, Ostomy | 2 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 2 |
| CAC | Apparatus, Autotransfusion | 1 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 |
| EFW | Toothbrush, Manual | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| FTY | Tape, Measuring, Rulers And Calipers | 1 |
| GMY | Antisera, Fluorescent, All Types, Escherichia Coli | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| JNT | Chromatographic, Phospholipids | 1 |
| JOL | Catheter And Tip, Suction | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 1 |
| KSG | Media, Potentiating For In Vitro Diagnostic Use | 1 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2018 | K181102 | ThermaCare Quick Therapy TENS Pfizer, Inc. | NUH |
| Sep 24, 1999 | K991620 | VISINE FOR CONTACTS Pfizer, Inc. | LPN |
| Jun 14, 1989 | K892264 | ORALCHEK SUPER-SOFT BRUSH Pfizer, Inc. | EFW |
| Jun 5, 1989 | K892360 | WATER JEL STERILE GEL-SOAKED BURN DRESSING Pfizer, Inc. | FRO |
| Jun 17, 1988 | K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE Pfizer, Inc. | LXI |
| Feb 24, 1986 | K854726 | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP Pfizer, Inc. | EXB |
| Jul 15, 1985 | K850840 | HOWMEDICA THREADED ACETABULAR COMPONENT Pfizer, Inc. | KWA |
| Jul 15, 1985 | K850443 | MEC ROD CONNECTOR Pfizer, Inc. | KTT |
| Jul 15, 1985 | K850413 | MEC HIP BOLT Pfizer, Inc. | KTT |
| Jul 15, 1985 | K850403 | MEC DISTAL FEMORAL BOLT Pfizer, Inc. | KTT |
| Jun 20, 1985 | K851971 | SERIES 7000/HOLTER RECORDER Pfizer, Inc. | DSH |
| Jun 17, 1985 | K852041 | DEKNATEL THORACIC CATHETER Pfizer, Inc. | JOL |
| May 23, 1985 | K851024 | PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE Pfizer, Inc. | CAC |
| Apr 19, 1985 | K850886 | COMPRESSION HIP SCREW SYSTEM Pfizer, Inc. | KIT |
| Apr 19, 1985 | K850444 | MEC BUTRESS PLATE Pfizer, Inc. | HRS |
| Apr 19, 1985 | K850442 | MEC BROAD BONE PLATE Pfizer, Inc. | HRS |
| Apr 19, 1985 | K850441 | MEC INTRAMEDULLARY ROD Pfizer, Inc. | HSB |
| Apr 19, 1985 | K850401 | LETOURNEL ACETABULAR PLATE Pfizer, Inc. | HRS |
| Jan 18, 1985 | K844938 | UNITED SKIN BARRIERS Pfizer, Inc. | EXB |
| Mar 12, 1980 | K792349 | SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. Pfizer, Inc. | JNT |
| Feb 19, 1980 | K791523 | VISALENS ALL PURPOSE SOLUTION FOR LENS Pfizer, Inc. | HPX |
| Nov 20, 1979 | K791524 | VISALENS CONCENTRATED CLEANER CONT LENS Pfizer, Inc. | HPX |
| Aug 3, 1979 | K791163 | PFIZER 0200FS LOCALLZER Pfizer, Inc. | JAK |
| Aug 3, 1979 | K791153 | ACTA-SCANNER 0220FS Pfizer, Inc. | JAK |
| Mar 6, 1979 | K790089 | TAPE MEASURE Pfizer, Inc. | FTY |
| Feb 1, 1979 | K782086 | AM-PEN SCREEN Pfizer, Inc. | JTO |
| Apr 24, 1978 | K780413 | LOW IIONIC STRENGTH SOLUTION Pfizer, Inc. | KSG |
| Dec 21, 1977 | K772291 | DIAG. CONSOLE, INDEPENDENT Pfizer, Inc. | JAK |
| Sep 15, 1977 | K771620 | ALKALINE PHOSPHATASE ISOENZY. SUB. SET Pfizer, Inc. | CIN |
| Jun 8, 1977 | K770833 | FLUORETEC-M Pfizer, Inc. | GMY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2018 | Pfizer Inc. 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 Terminated |
IMD | None listed |
| Oct 2, 2018 | Pfizer Inc. 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. Terminated |
IMD | None listed |
| Oct 2, 2018 | Pfizer Inc. 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 ove Terminated |
IMD | None listed |