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: Cleared only ×
174,955 results
105865–105888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1994
ETEST FOR AMPICILLIN/SULBACTAM 2/1
K935519 · JWY
Ab Biodisk North America, Inc.
Microbiology · 351d
Cleared Nov 04, 1994
SIGMA ELITE
K936046 · CAD
Penlon, Inc.
Anesthesiology · 319d
Cleared Nov 04, 1994
MEDTRONIC MODEL 4558M
K940703 · DTB
Medtronic Vascular
Cardiovascular · 261d
Cleared Nov 04, 1994
K-10-VS, DA-05-VS, RECORDING ELECTRODES
K941568 · GXY
Medicotest, Inc.
Neurology · 218d
Cleared Nov 04, 1994
CLARUS NEUROPEN MODEL 2120
K942249 · GWG
Clarus Medical Systems, Inc.
Neurology · 179d
Cleared Nov 04, 1994
VARIOUSPATIENT MONITORING CABLE
K942321 · DSA
Merit Cables Incorporated
Cardiovascular · 175d
Cleared Nov 04, 1994
PROXIDERM (TENTATIVE)
K942425 · MKY
Progressive Surgical Products, Inc.
General & Plastic Surgery · 168d
Cleared Nov 04, 1994
SMILE INTEGRATED PROPHYLAXIS PASTE RINGS
K942851 · EJR
Germiphene Corp.
Dental · 141d
Cleared Nov 04, 1994
REPLACEMENT BATTERIES
K943632 · FCO
National Custom Ent., Inc.
Gastroenterology & Urology · 101d
Cleared Nov 04, 1994
NCE REPLACEMENT BATTERIES
K943680 · FCO
National Custom Ent., Inc.
Gastroenterology & Urology · 101d
Cleared Nov 04, 1994
CANNABINOID EIA ASSAY
K943998 · LDJ
Diagnostic Reagents, Inc.
Toxicology · 136d
Cleared Nov 04, 1994
MENISCUS CHIN IMPLANT
K944164 · LZK
Spectrum Designs, Inc.
General & Plastic Surgery · 70d
Cleared Nov 04, 1994
SILHOUETTE MALAR IMPLANT
K944165 · LZK
Spectrum Designs, Inc.
General & Plastic Surgery · 70d
Cleared Nov 04, 1994
DORSAL COLUMELLA IMPLANT
K944166 · LZK
Spectrum Designs, Inc.
General & Plastic Surgery · 70d
Cleared Nov 04, 1994
SURE-LOCK VENTILATOR TUBING HOLDER
K944324 · BTR
B&B Medical Technologies, Inc.
Anesthesiology · 63d
Cleared Nov 04, 1994
FIBEROPTIC LARYNGOSCOPE HANDLE
K944686 · CCW
Fiberoptic Medical Products, Inc.
Anesthesiology · 42d
Cleared Nov 04, 1994
CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,
K944923 · JJT
Clinical Controls, Inc.
Chemistry · 29d
Cleared Nov 04, 1994
BREAST LESION LOCALIZATION NEEDLE
K944942 · GDF
Promedical , Ltd.
General & Plastic Surgery · 28d
Cleared Nov 04, 1994
AMPLATZ SUPER STIFF GUIDEWIRE
K944959 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 28d
Cleared Nov 04, 1994
ORIGIN PIXIE STIC INTRODUCER SLEEVE
K945023 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 22d
Cleared Nov 04, 1994
MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE
K945102 · FFS
Alm Surgical Equipment, Inc.
Gastroenterology & Urology · 17d
Cleared Nov 03, 1994
BABCOCK/BOWEL CLAMP FORCEPS
K940790 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 254d
Cleared Nov 03, 1994
PARADERM -585M DERMATOLOGICAL LASER
K941559 · GEX
Paradigm Lasers, Inc.
General & Plastic Surgery · 216d
Cleared Nov 03, 1994
JENNINGS JAVELIN
K942548 · FMK
Jfi Endineering, Inc.
General & Plastic Surgery · 156d