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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82345–82368 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
K001036 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared Jun 06, 2000
BONASSE CONTACT LENS CASE
K991206 · LRX
Bonasse Ent. Co., Ltd.
Ophthalmic · 424d
Cleared Jun 06, 2000
THE WAND
K992404 · FMF
Spintech, Inc.
General Hospital · 323d
Cleared Jun 06, 2000
C.S.O. TONOMETER
K992835 · HKY
Cso
Ophthalmic · 288d
Cleared Jun 05, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K000001 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 154d
Cleared Jun 05, 2000
MEDTRONIC AVE BRIDGE X3 STENT
K000744 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 05, 2000
MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
K000767 · KNY
Memcath Technologies, LLC
Gastroenterology & Urology · 88d
Cleared Jun 05, 2000
AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700
K000820 · DQO
Endosonics Corp.
Cardiovascular · 84d
Cleared Jun 05, 2000
STAT-SHELL DISPOSABLE SP02 SENSOR
K000831 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 83d
Cleared Jun 05, 2000
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
K000882 · MHX
Datex-Ohmeda
Cardiovascular · 77d
Cleared Jun 05, 2000
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC)...
K000998 · LPN
Optisonic, Inc.
Ophthalmic · 74d
Cleared Jun 05, 2000
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
K001597 · GCJ
Conmedcorp
General & Plastic Surgery · 13d
Cleared Jun 05, 2000
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
K990435 · CAF
Apex Medical Corp.
Anesthesiology · 480d
Cleared Jun 05, 2000
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT...
K993772 · DTZ
Terumo Medical Corp.
Cardiovascular · 210d
Cleared Jun 05, 2000
BOFOR REVISION COUP
K993874 · LZO
Plus Orthopedics
Orthopedic · 203d
Cleared Jun 05, 2000
NEPHROSCOPE, 12 DEGREES
K994223 · FGA
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 173d
Cleared Jun 03, 2000
MEROGEL OTOLOGIC PACK
K001148 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 54d
Cleared Jun 03, 2000
TRIFIX SPINAL FIXATION SYSTEM
K001627 · MNH
Endius, Inc.
Orthopedic · 8d
Cleared Jun 02, 2000
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
K000164 · LPN
Allergan, Inc.
Ophthalmic · 135d
Cleared Jun 02, 2000
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
K001017 · MEG
Retrax Safety Systems, Inc.
General Hospital · 65d
Cleared Jun 02, 2000
AUDIOSCREENER OAE + ABR
K001058 · EWO
Kedly, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 02, 2000
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
K001285 · JIF
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Jun 02, 2000
DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
K001336 · KPR
Analogic Corp.
Radiology · 36d
Cleared Jun 02, 2000
DR5000 DEDICATED CHEST X-RAY SYSTEM
K001341 · KPR
Analogic Corp.
Radiology · 36d