FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,766 results
10969–10992 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 12, 1994
SAFE-PICC CATHETER
K930048 · FOZ
Menlo Care, Inc.
General Hospital · 492d
Cleared May 12, 1994
LONZA FORMULATION R-82
K932277 · LRJ
Calgon Vestal Div.
General Hospital · 365d
Cleared May 12, 1994
LONZA FORMULATION R-82
K932502 · LRJ
Lonza, Inc.
General Hospital · 365d
Cleared May 12, 1994
CLESTRACLEAN(R) ROOM AIR PURIFIER
K932803 · FRA
Clestra Cleanroom Technology, Inc.
General Hospital · 337d
Cleared May 12, 1994
NYLON LINER GLOVES
K940274 · LYU
Wells Lamont Corp.
General Hospital · 111d
Cleared May 12, 1994
STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE
K941302 · KKX
Cush Industries, Inc.
General Hospital · 56d
Cleared May 12, 1994
WOUND DRESSING KIT
K941467 · FRG
Clinical Resources, Inc.
General Hospital · 45d
Cleared May 12, 1994
DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
K941468 · FRG
Clinical Resources, Inc.
General Hospital · 45d
Cleared May 12, 1994
CENTRAL LINE DRESSING CHANGE TRAY
K941471 · FRG
Clinical Resources, Inc.
General Hospital · 45d
Cleared May 11, 1994
THORA-CATH
K941232 · JOL
Gesco Intl., Inc.
General Hospital · 57d
Cleared May 09, 1994
AUTOMATIC NEEDLE DISCONECT (A.N.D.)
K925086 · FMI
Post Medical, Inc.
General Hospital · 579d
Cleared May 09, 1994
ISOFLUX IXP FLOW REGULATOR
K925731 · FPA
Ferguson Medical
General Hospital · 542d
Cleared May 09, 1994
ISOFLUX IXZ FLOW REGULATOR
K925732 · FPA
Ferguson Medical
General Hospital · 542d
Cleared May 09, 1994
ISOFLUX IXL FLOW REGULATOR
K925733 · FPA
Ferguson Medical
General Hospital · 542d
Cleared May 09, 1994
PRIMUS PSS SERIES STERILIZERS
K926185 · FLE
Primus Sterilizer Co., Inc.
General Hospital · 517d
Cleared May 09, 1994
INSTRU KLENZ
K935063 · FLG
Calgon Corp.
General Hospital · 200d
Cleared May 09, 1994
COMFIT
K935464 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 178d
Cleared May 09, 1994
POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
K935864 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 157d
Cleared May 09, 1994
SIME SURGICAL LATEX GLOVE
K940797 · KGO
Sime Health, Ltd.
General Hospital · 76d
Cleared May 09, 1994
POWDER FREE LATEX EXMINATION GLOVES
K941754 · LYY
Sj Medical Products (M) Sdn Bhd
General Hospital · 31d
Cleared May 05, 1994
ABDOMINAL / THORACIC PATIENT DRAPE
K930815 · KKX
Custom Medical Products, Ltd.
General Hospital · 442d
Cleared May 05, 1994
CATH-FINDER
K931073 · FOZ
Pharmacia Deltec, Inc.
General Hospital · 429d
Cleared May 05, 1994
SURGICAL DRAPE
K931418 · KKX
Custom Medical Products, Ltd.
General Hospital · 409d
Cleared May 05, 1994
HEAD SHEET
K931455 · KKX
Custom Medical Products, Ltd.
General Hospital · 408d