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
78793–78816 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 2001
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
K011170 · HRS
Synthes (Usa)
Orthopedic · 79d
Cleared Jul 05, 2001
MOBILE-PATIENT VIEWER
K011436 · DPS
Data Critical Corporation
Cardiovascular · 56d
Cleared Jul 05, 2001
IN TEN-S
K011492 · EBF
Ivoclar North America, Inc.
Dental · 51d
Cleared Jul 05, 2001
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713 · LZA
Kimberly-Clark Corp.
General Hospital · 31d
Cleared Jul 05, 2001
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
K011731 · JJY
Medical Analysis Systems, Inc.
Chemistry · 30d
Cleared Jul 05, 2001
POWDERED LATEX EXAMINATION GLOVES
K011922 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 15d
Cleared Jul 03, 2001
PRAIRIE CRUISER
K002580 · ITI
Raye'S, Inc.
Physical Medicine · 319d
Cleared Jul 03, 2001
BODYSTAT
K002835 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 294d
Cleared Jul 03, 2001
SMART RAD
K003438 · MQB
Cmt Medical Technologies, Ltd.
Radiology · 239d
Cleared Jul 03, 2001
HYALOMATRIX CO
K003855 · KHJ
Fidia Advanced Biopolymers Srl
Ear, Nose, Throat · 202d
Cleared Jul 03, 2001
SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE...
K011032 · LYC
Harvest Technologies, Corp.
Dental · 89d
Cleared Jul 03, 2001
WATERLASE, MILLENNIUM
K011041 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 89d
Cleared Jul 03, 2001
ETYMOTIC RESEARCH ER-10D OAE PROBE
K011114 · EWO
Etymotic Research
Ear, Nose, Throat · 82d
Cleared Jul 03, 2001
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
K011141 · JAK
Shimadzu Corp.
Radiology · 81d
Cleared Jul 03, 2001
STARBAND CRANIAL ORTHOSIS
K011350 · OAN
Orthomerica Products, Inc.
Neurology · 62d
Cleared Jul 03, 2001
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX,...
K011734 · DRF
Mogul Enterprises
Cardiovascular · 28d
Cleared Jul 03, 2001
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
K011766 · DRF
St Jude Medical
Cardiovascular · 26d
Cleared Jul 03, 2001
BIOZTECT SENSOR AND BIOZTECT CABLE
K011797 · DSB
Cardiodynamics International Corp.
Cardiovascular · 25d
Cleared Jul 02, 2001
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
K010599 · GJS
International Technidyne Corp.
Hematology · 124d
Cleared Jul 02, 2001
M2A ACETABULAR SYSTEM
K011110 · KWA
Biomet, Inc.
Orthopedic · 82d
Cleared Jul 02, 2001
TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS
K011171 · HIL
Procter & Gamble Co.
Obstetrics & Gynecology · 76d
Cleared Jul 02, 2001
PROVIEW EYE PRESSURE MONITOR
K011199 · HKY
Bausch & Lomb, Inc.
Ophthalmic · 74d
Cleared Jul 02, 2001
RANDOX DIGOXIN
K011302 · KXT
Randox Laboratories, Ltd.
Toxicology · 63d
Cleared Jul 02, 2001
RANDOX PHENOBARBITAL
K011303 · DLZ
Randox Laboratories, Ltd.
Toxicology · 63d