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.

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

Filters: Cleared only ×
175,230 results
37777–37800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2014
DIODE LASER FOR HIAR REMOVAL
K131838 · GEX
Beijing Honkon Technologies Co., Ltd.
General & Plastic Surgery · 308d
Cleared Apr 24, 2014
QUICK RELAX PRO
K131956 · NUH
Healthcare Innovations, LLC
Neurology · 301d
Cleared Apr 24, 2014
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 262d
Cleared Apr 24, 2014
PINOOK STIMULATOR
K132563 · NUH
Pinook USA
Neurology · 252d
Cleared Apr 24, 2014
ELECTRIC BREAST PUMP
K132882 · HGX
Shantou Xinghe Electrical Apparatuses...
Obstetrics & Gynecology · 223d
Cleared Apr 24, 2014
COUNTER OTC TENS DEVICE
K132993 · NUH
Counter Scientific Development (Gz),...
Neurology · 212d
Cleared Apr 24, 2014
DX3000-L
K133007 · MUH
Dexcowin Co., Ltd.
Radiology · 211d
Cleared Apr 24, 2014
DISCOVERY IGS 740
K133278 · OWB
GE Medical Systems SCS
Radiology · 182d
Cleared Apr 24, 2014
FLUID LEVEL MONITOR
K133870 · FLN
Coleman Laboratories
General Hospital · 125d
Cleared Apr 24, 2014
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL,...
K134013 · JJY
Bio-Rad Laboratories
Immunology · 115d
Cleared Apr 24, 2014
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB,...
K140080 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 100d
Cleared Apr 24, 2014
POLARIS SPINAL SYSTEM -TRANSLATION SCREW
K140123 · NKB
Ebi, LLC
Orthopedic · 98d
Cleared Apr 24, 2014
MONOFILAMENT POLYPECTOMY SNARE
K140763 · FDI
United States Endoscopy
Gastroenterology & Urology · 28d
Cleared Apr 23, 2014
EUM 100PRO
K131889 · OSP
Promedic, Inc.
Obstetrics & Gynecology · 302d
Cleared Apr 23, 2014
PATIENT MONITOR
K132077 · MHX
Advanced Instrumentations, Inc.
Cardiovascular · 292d
Cleared Apr 23, 2014
ACCUTIP COVER
K132549 · HKY
Accutome, Inc.
Ophthalmic · 252d
Cleared Apr 23, 2014
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
K132595 · HEB
Ontex Bvba
Obstetrics & Gynecology · 247d
Cleared Apr 23, 2014
NASAL MASK, NASAL MASK, FULL FACE MASK
K133009 · BZD
BMC Medical Co., Ltd.
Anesthesiology · 210d
Cleared Apr 23, 2014
XQ-1 INCUBATOR
K133742 · MQG
At Medical Uab
Obstetrics & Gynecology · 135d
Cleared Apr 23, 2014
CENTERVUE MACULAR INTEGRITY ASSESSMENT
K133758 · HLI
Centervue S.P.A.
Ophthalmic · 133d
Cleared Apr 23, 2014
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
K133897 · OGZ
Infraredx, Inc.
Cardiovascular · 124d
Cleared Apr 23, 2014
FORTRESS PEDICLE SCREW SYSTEM
K140010 · NKB
Spineology, Inc.
Orthopedic · 111d
Cleared Apr 23, 2014
DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
K140445 · LLZ
Imaging Sciences International, LLC
Radiology · 61d
Cleared Apr 23, 2014
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND...
K140561 · PCU
Xlumena, Inc.
Gastroenterology & Urology · 49d