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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133273–133296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1988
RIA/MAT FPA TEST KIT
K884496 · DAN
Altana, Inc.
Immunology · 22d
Cleared Nov 16, 1988
ADULT RESUSCITATOR WITH MASK AND FILTER
K884526 · BTM
Intertech/Ohio
Anesthesiology · 20d
Cleared Nov 15, 1988
AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030
K881056 · JJC
American Research Products Co.
Chemistry · 249d
Cleared Nov 15, 1988
OLYMPUS GF-UM3/EU-M3
K882061 · GDB
Olympus Corp.
Gastroenterology & Urology · 183d
Cleared Nov 15, 1988
DTL MICROTOUCH EYE ELECTRODE
K882464 · GXY
Lectromedics, Inc.
Neurology · 153d
Cleared Nov 15, 1988
BARD(R) URETERAL STENT W/SUTURE
K883561 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 15, 1988
MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)
K883604 · LLZ
Medrad, Inc.
Radiology · 83d
Cleared Nov 15, 1988
CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.
K883738 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 75d
Cleared Nov 15, 1988
.2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.
K883926 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 61d
Cleared Nov 15, 1988
SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
K884360 · HQG
Seiko Corp.
Ophthalmic · 29d
Cleared Nov 14, 1988
STERNAL POWER AWL
K873766 · KIJ
Bowen & Company, Inc.
Orthopedic · 425d
Cleared Nov 14, 1988
NEEDLE REMOVER
K881866 · FMF
Howard, Hills & Harsh
General Hospital · 195d
Cleared Nov 14, 1988
FLUIDAIR
K881917 · INX
Kinetic Concepts, Inc.
Physical Medicine · 189d
Cleared Nov 14, 1988
OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
K882391 · DXY
Ela Medical, Inc.
Cardiovascular · 157d
Cleared Nov 14, 1988
FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE
K883120 · EJF
Flexmedics
Dental · 111d
Cleared Nov 14, 1988
DONALDSON VENTILATION TUBES PT. # AG/S9
K883667 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 80d
Cleared Nov 14, 1988
FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS
K883705 · FXX
Select Sources, Inc.
General Hospital · 76d
Cleared Nov 14, 1988
TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM
K883756 · LNH
Toshiba Medical Systems
Radiology · 69d
Cleared Nov 14, 1988
VAS-CATH CATHETER REPAIR KIT
K883768 · LFJ
Vas-Cath, Inc.
Gastroenterology & Urology · 69d
Cleared Nov 14, 1988
H.A.C. MODEL-A (ALL IN THE EAR)
K883772 · ESD
Hearing Aid Crafters
Ear, Nose, Throat · 69d
Cleared Nov 14, 1988
H.A.C. MODEL-B (ALL IN THE CANAL)
K883773 · ESD
Hearing Aid Crafters
Ear, Nose, Throat · 69d
Cleared Nov 14, 1988
WALLABY(TM) BLANKET
K883779 · LBI
Fiberoptic Medical Products, Inc.
General Hospital · 69d
Cleared Nov 14, 1988
C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR
K884086 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 48d
Cleared Nov 14, 1988
HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET
K884156 · FPK
Sechrist Industries, Inc.
General Hospital · 41d