FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,808 results
12001–12024 of 17,808
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 06, 1992
FLO-GARD 8000 HALF-SET
K915499 · FRN
Baxter Healthcare Corp
General Hospital · 88d
Cleared Mar 04, 1992
DISPOSABLE INTROSSEOUS INFUSION NEEDLES
K913258 · FMI
Cook, Inc.
General Hospital · 225d
Cleared Mar 04, 1992
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
K913931 · FRN
Abbott Laboratories
General Hospital · 188d
Cleared Mar 04, 1992
INTRAOSSEOUS ACCESS NEEDLE
K915409 · FMI
Cook, Inc.
General Hospital · 93d
Cleared Feb 28, 1992
FLO-GARD(R) 6201
K915522 · FRN
Baxter Healthcare Corp
General Hospital · 80d
Cleared Feb 28, 1992
FLO-GARD(R) 6301
K915523 · FRN
Baxter Healthcare Corp
General Hospital · 80d
Cleared Feb 27, 1992
STERILETX POWDER FREE LATEX EXAMINATION GLOVES
K915189 · LYY
Transcorp
General Hospital · 101d
Cleared Feb 20, 1992
FOIL BABY BUNTING
K915303 · KME
Gam Industries, Inc.
General Hospital · 91d
Cleared Feb 18, 1992
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
K912444 · LGM
Radiometer America, Inc.
General Hospital · 260d
Cleared Feb 14, 1992
3100 INFUSION PUMP
K912192 · FRN
Graseby Medical , Ltd.
General Hospital · 273d
Cleared Feb 14, 1992
3000 INFUSION PUMP
K912193 · FRN
Graseby Medical , Ltd.
General Hospital · 273d
Cleared Feb 14, 1992
ACACIAS PHARM/PUMP
K912771 · LHI
Acacia, Inc.
General Hospital · 235d
Cleared Feb 14, 1992
SURGICAL APPAREL
K914832 · FXX
W.L. Gore & Associates, Inc.
General Hospital · 112d
Cleared Feb 12, 1992
STABILET INFANT RADIANT WARMER MODEL 2000C
K913945 · FMT
Hill-Rom, Inc.
General Hospital · 161d
Cleared Feb 12, 1992
I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR
K914118 · FYD
I.C Medical, Inc.
General Hospital · 152d
Cleared Feb 11, 1992
INJECTION CAP
K913337 · FPA
Cp Medical
General Hospital · 200d
Cleared Feb 11, 1992
EXCELSIOR SINGLE LEAD DISPENSING SET
K913804 · LHI
Excel Medical, Inc.
General Hospital · 169d
Cleared Feb 11, 1992
I.V.IRRIGATION POLE
K915065 · FOZ
American Medical Mfg., Inc.
General Hospital · 95d
Cleared Feb 11, 1992
KEITH A-GAURD
K915107 · LYY
Kbk Medical Products, Inc.
General Hospital · 90d
Cleared Feb 11, 1992
LATEX MED.EXAM.GLOVES POWDERED AMBIDEXTROUS
K915126 · LYY
Hedd Roz Canada, Inc.
General Hospital · 90d
Cleared Feb 11, 1992
MED.EXAM.GLOVES POWDERED ANATOMICALLY CORRECT
K915127 · LYY
Hedd Roz Canada, Inc.
General Hospital · 90d
Cleared Feb 11, 1992
PRIMARY DRESSING TRAY
K915140 · LYY
Mediflex Intl.
General Hospital · 90d
Cleared Feb 07, 1992
DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599
K913447 · KKX
Graham Medical Products
General Hospital · 189d
Cleared Feb 07, 1992
DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE
K913448 · KKX
Graham Medical Products
General Hospital · 189d