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
93289–93312 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1997
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER
K971646 · DQO
Cordis Corp.
Cardiovascular · 70d
Cleared Jul 14, 1997
SNT STEREOTACTIC LOCALIZATION SYSTEM
K971675 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 68d
Cleared Jul 14, 1997
ETEST FOR LEVOFLOXACIN
K971697 · JWY
Ab Biodisk
Microbiology · 67d
Cleared Jul 14, 1997
ECHOVACS
K971776 · LLZ
Vmi Technologies
Radiology · 62d
Cleared Jul 14, 1997
AUTOMATED CHAMBER MAINTENANCE MODULE
K971795 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 60d
Cleared Jul 14, 1997
QUIKSTRIP ONE STEP COCAINE TEST
K971926 · DIO
Drial Consultants, Inc.
Toxicology · 48d
Cleared Jul 14, 1997
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE
K971945 · KGO
Tillotson Healthcare Corp.
General Hospital · 48d
Cleared Jul 14, 1997
THYROGLOBULIN ASSAY SYSTEM
K972190 · JZO
American Laboratory Products Co., Ltd.
Immunology · 56d
Cleared Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
K972286 · GJT
Universal Reagents, Inc.
Hematology · 25d
Cleared Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
K972288 · GGP
Universal Reagents, Inc.
Hematology · 25d
Cleared Jul 14, 1997
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
K972330 · LGQ
Oxis Intl., Inc.
Toxicology · 21d
Cleared Jul 14, 1997
FOVS, BRILLARTE, ETC...
K972362 · HQY
Sunglass City, Inc.
Ophthalmic · 19d
Cleared Jul 11, 1997
CELL ROBOTICS ER: YAG SURGICAL LASER
K970461 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 155d
Cleared Jul 11, 1997
MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
K971105 · DTN
Avecor Cardiovascular, Inc.
Cardiovascular · 107d
Cleared Jul 11, 1997
ALLEN, ULTRA AND SMART SOCKETS
K971988 · FQO
Allen Medical Systems, Inc.
General & Plastic Surgery · 43d
Cleared Jul 10, 1997
ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K964190 · DTE
Biotronik, Inc.
Cardiovascular · 262d
Cleared Jul 10, 1997
SOMNITOR 32K SLEEP ACTIVITY MONITOR
K965079 · LEL
Neurim Pharmaceuticals, Ltd.
Neurology · 203d
Cleared Jul 10, 1997
MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
K970051 · HCC
Smith and Nephew Donjoy, Inc.
Neurology · 184d
Cleared Jul 10, 1997
FLOTEC OXYSAVRR (S)
K970371 · NFB
Flotec, Inc.
Anesthesiology · 160d
Cleared Jul 10, 1997
FAR-EAST BOUFFANT CAPS
K970988 · LYU
Far East Science & Technology...
General Hospital · 114d
Cleared Jul 10, 1997
FAR-EAST SHOE COVERS
K971191 · FXP
Far East Science & Technology...
General Hospital · 101d
Cleared Jul 10, 1997
SOMA 900 TRANSPORT BED
K971546 · FNL
Nova Technologies, Inc.
General Hospital · 73d
Cleared Jul 10, 1997
TRANS VAGINAL NEEDLE GUIDE
K971722 · ITX
Protek Medical Products, Inc.
Radiology · 62d
Cleared Jul 10, 1997
ACTA OEM MODULE
K972006 · EBZ
Interactive Consulting, Inc.
Dental · 41d