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
40321–40344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 2013
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
K123598 · JDI
Smith & Nephew, Inc.
Orthopedic · 219d
Cleared Jun 28, 2013
ET SMARTFIT ABUTMENT
K123627 · NHA
Hiossen, Inc.
Dental · 217d
Cleared Jun 28, 2013
SURECALL LABOR MONITOR
K130002 · OSP
Reproductive Research Technologies, LP
Obstetrics & Gynecology · 177d
Cleared Jun 28, 2013
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
K130638 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 109d
Cleared Jun 28, 2013
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
K130724 · LLZ
Straumann USA
Radiology · 102d
Cleared Jun 28, 2013
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
K130808 · NHA
Straumann USA
Dental · 95d
Cleared Jun 28, 2013
ZOE FLUID STATUS MONITOR
K131509 · DSB
Noninvasive Medical Technologies, Inc.
Cardiovascular · 35d
Cleared Jun 28, 2013
SUDO PATH
K131568 · GZO
Ld Technology, LLC
Neurology · 29d
Cleared Jun 28, 2013
QUICKVUE INFLUENZA A+B
K131619 · GNX
Quidel Corp.
Microbiology · 25d
Cleared Jun 27, 2013
LASERBRUSH
K121920 · OAP
Sunetics International Marketing...
General & Plastic Surgery · 360d
Cleared Jun 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
K123404 · LON
Becton, Dickinson & CO
Microbiology · 234d
Cleared Jun 27, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K130094 · NBW
Abbott Diabetes Care
Chemistry · 168d
Cleared Jun 27, 2013
AXLE INTERSPINOUS FUSION SYSTEM
K130438 · PEK
X-Spine Systems, Inc.
Orthopedic · 126d
Cleared Jun 27, 2013
LYRIC2
K130790 · ESD
Phonak, LLC
Ear, Nose, Throat · 97d
Cleared Jun 27, 2013
STREAMLINE TL SPINAL SYSTEM
K131100 · NKB
Pioneer Surgical Technology, Inc.
Orthopedic · 69d
Cleared Jun 27, 2013
EARPROBE
K131141 · GWJ
Path Medical GmbH
Neurology · 65d
Cleared Jun 27, 2013
KEELER SLIT LAMP H-SERIES
K131589 · HJO
Keeler, Ltd.
Ophthalmic · 27d
Cleared Jun 27, 2013
STARCHMARK BREAST TISSUE MARKER
K131654 · NEU
Senorx, Inc.
General & Plastic Surgery · 21d
Cleared Jun 27, 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
K131683 · MBI
Depuy Mitek, Inc., A Johnson and...
Orthopedic · 17d
Cleared Jun 26, 2013
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
K122653 · KNT
Kimberly Clark Corporation
Gastroenterology & Urology · 299d
Cleared Jun 26, 2013
KSEA BIPOLAR ELECTRODE
K122983 · HIN
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 273d
Cleared Jun 26, 2013
23GA CURVED ILLUMINATING LASER PROBE
K122997 · HQB
Peregrine Surgical , Ltd.
Ophthalmic · 272d
Cleared Jun 26, 2013
BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
K123266 · LON
Becton, Dickinson and Company
Microbiology · 250d
Cleared Jun 26, 2013
HEMOCONCENTRATOR
K123288 · KDI
Maquet Cardiopulmonary, AG
Gastroenterology & Urology · 247d