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
157513–157536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1983
ABDUCTION PILLOW
K830243 · IOZ
Warm & Form, Orthopedic Materials
Physical Medicine · 42d
Cleared Mar 08, 1983
DEVO'N LOOPS
K830248 · KDC
Devon Industries, Inc.
General & Plastic Surgery · 42d
Cleared Mar 08, 1983
FLORET PEANUT SPONGE/STICK & GAUZE PREP
K830274 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 42d
Cleared Mar 08, 1983
NEEDELET HANDLER FOR SHARPS
K830275 · MMK
Ritmed, Inc.
General Hospital · 42d
Cleared Mar 08, 1983
DUOWIPE CAUTERY TIP & INSTRUMENT CLEANER
K830277 · GEI
Ritmed, Inc.
General & Plastic Surgery · 42d
Cleared Mar 08, 1983
REINFORCED SILICONE TRACHEAL TUBE
K830352 · BTR
Portex, Inc.
Anesthesiology · 33d
Cleared Mar 08, 1983
NEISSERIA IDENTIFICATION DISCS
K830364 · JSX
Oxoid U.S.A., Inc.
Microbiology · 32d
Cleared Mar 08, 1983
POWER FLEX
K830369 · BXB
Biodynamic Technologies of Florida
Physical Medicine · 32d
Cleared Mar 08, 1983
FILDES ENRICHMENT SOLUTON
K830383 · KZI
Gibco Laboratories Life Technologies,...
Microbiology · 32d
Cleared Mar 08, 1983
UREA-PDA DISK
K830396 · JSS
Remel Co.
Microbiology · 29d
Cleared Mar 08, 1983
LIGACLIP TITANIUM LIGATING CLIP
K830503 · FZP
Ethicon, Inc.
General & Plastic Surgery · 20d
Cleared Mar 08, 1983
MILLONIGS MODIFIED PHOSPHATE BUFFERED
K830514 · IFP
Surgipath Medical Industries, Inc.
Pathology · 19d
Cleared Mar 08, 1983
MULTI-SIGNAL AUDITORY STIMULATOR SM700
K830579 · GWJ
Nicolet Biomedical Instruments
Neurology · 13d
Cleared Mar 07, 1983
DOUBLE LUMEN SUBCLAVIAN CATHETER
K823135 · LFJ
Abbott Laboratories
Gastroenterology & Urology · 130d
Cleared Mar 07, 1983
AUTO-TENS MODEL III DUAL CHANNEL REPLACE
K823466 · GZJ
Cbc Corp.
Neurology · 108d
Cleared Mar 07, 1983
RESPITRACE SYSTEM
K823782 · BZK
Respitrace Corp.
Anesthesiology · 82d
Cleared Mar 07, 1983
PARAGON IMMUNOELECTROPHORESIS REAGENT
K823884 · CFF
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Mar 07, 1983
MYOGRAPH 2000
K830058 · BXN
Prothia USA, Inc.
Anesthesiology · 59d
Cleared Mar 07, 1983
UNICIDE
K830106 · LFE
North Pacific Dental, Inc.
Dental · 55d
Cleared Mar 07, 1983
MINIATURE ION SELECTIVE ELECTRODES
K830130 · JSG
Ionetics, Inc.
Chemistry · 55d
Cleared Mar 07, 1983
BETA-CAP D ADAPTER
K830208 · FKX
Quinton, Inc.
Gastroenterology & Urology · 45d
Cleared Mar 07, 1983
FECAL OCCULT SLIDE TEST KIT
K830223 · KHE
Cambridge Chemical Products, Inc.
Chemistry · 42d
Cleared Mar 07, 1983
OTOLOGICAL VENTILATION TUBES-VARIOUS
K830228 · ETD
Micromedics, Inc.
Ear, Nose, Throat · 42d
Cleared Mar 07, 1983
DIPCHEX DIP-SLIDE CULTURE SYS
K830252 · JXA
Granite Diagnostics, Inc.
Microbiology · 41d