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
92785–92808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 10, 1997
POST-STOP EPISTAXIS CATHETER
K972078 · EMX
Boston Medical Products, Inc.
Ear, Nose, Throat · 37d
Cleared Jul 10, 1997
PRO CHECK DIGITAL PACIFIER THERMOMETER
K972259 · FLL
Micro Weiss Electronics
General Hospital · 23d
Cleared Jul 09, 1997
RPI DUAL PORT IRRIGATION ADAPTER
K964920 · KNT
Ridge Products, Inc.
Gastroenterology & Urology · 212d
Cleared Jul 09, 1997
ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
K970011 · FLL
Medical Data Electronics
General Hospital · 188d
Cleared Jul 09, 1997
THERAPLAN PLUS VERSION 1.2
K970236 · IYE
Theratronics, Inc.
Radiology · 169d
Cleared Jul 09, 1997
34MM SCARF THREAD-HEAD(TM) SCREW
K971068 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
TWIST-OFF (TM) SCREW
K971069 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
SCARF THREAD-HEAD (TM) HEAD SCREW
K971070 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
K971079 · KQX
Interlogics, Inc.
Neurology · 106d