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
12097–12120 of 17,808
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 22, 1991
PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM
K911782 · FRN
Strato Medical Corp.
General Hospital · 214d
Cleared Nov 22, 1991
EASY ACCESS BED
K911893 · FNL
Willis Therapeutic Innovations, Inc.
General Hospital · 207d
Cleared Nov 22, 1991
INCUBATOR 8000 IC
K913394 · FMZ
Dragerwerk AG
General Hospital · 115d
Cleared Nov 22, 1991
PRC AUTOPSY DEVICE
K913536 · KKX
Pennstate
General Hospital · 105d
Cleared Nov 22, 1991
INCUBATOR 8000 SC
K914134 · FMZ
National Draeger, Inc.
General Hospital · 115d
Cleared Nov 21, 1991
SNAP-LOCK MICRO PORT, MODIFICATION
K910448 · LJT
Infusaid Corp.
General Hospital · 303d
Cleared Nov 15, 1991
SAS RUBBER PRODUCTS CO./LATEX EXAMINATION GLOVES
K911939 · LYY
Overseas Import & Export Dist.
General Hospital · 199d
Cleared Nov 13, 1991
MODEL C386 ISOLETTE(R) INFANT INCUBATOR
K913291 · FMZ
Air-Shields, Inc.
General Hospital · 112d
Cleared Nov 08, 1991
DANBY D.S.P. SYRINGE PUMP
K911103 · FRN
Isys Medical , Ltd.
General Hospital · 241d
Cleared Nov 07, 1991
BAXA PCA INFUSOR
K910257 · MEA
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 289d
Cleared Nov 07, 1991
RELIABLE CONE STYLE FACE MASK
K913558 · FXX
Anago, Inc.
General Hospital · 90d
Cleared Nov 07, 1991
PATIENT EXAMINATION GLOVES
K913776 · LYY
P.T. Irama Dinamika Latex
General Hospital · 86d
Cleared Nov 07, 1991
PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF
K914628 · LYY
Medical Resources, Ltd.
General Hospital · 86d
Cleared Nov 05, 1991
INFU.DISK
K904619 · FRN
Electrochemical Drug Delivery, Inc.
General Hospital · 390d
Cleared Nov 05, 1991
SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM
K912909 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 126d
Cleared Nov 01, 1991
NORTEC CONNECTING TUBE SET
K911865 · GAZ
North American Sterilization &...
General Hospital · 189d
Cleared Nov 01, 1991
SMOKE/ODOR EVACUATOR #757
K912612 · FYD
Olsen Electrosurgical, Inc.
General Hospital · 142d
Cleared Nov 01, 1991
BONE-TEMNO/STERNUM-TEMNO
K913306 · LWE
Proact, Ltd.
General Hospital · 99d
Cleared Nov 01, 1991
SURGI-SPRAY O.R. IRRIGATION SYSTEM
K913568 · FQH
Phoenix Surgical Products, Inc.
General Hospital · 84d
Cleared Oct 31, 1991
DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH
K913235 · FMF
Davol, Inc.
General Hospital · 101d
Cleared Oct 31, 1991
MEGA ARTHROGRAM KIT
K913317 · FMI
Mega Medical, Inc.
General Hospital · 98d
Cleared Oct 30, 1991
C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM
K912910 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 120d
Cleared Oct 30, 1991
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K913718 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 30, 1991
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · FRN
Abbott Laboratories
General Hospital · 90d