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
78289–78312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 02, 2001
I-STAT SYSTEM
K011478 · KHP
I-Stat Corp.
Chemistry · 49d
Cleared Jul 02, 2001
10% PVP
K011481 · MQL
Conception Technologies
Obstetrics & Gynecology · 49d
Cleared Jul 02, 2001
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE...
K011505 · CEW
Diagnostic Products Corp.
Chemistry · 47d
Cleared Jul 02, 2001
HYALURONIDASE IN HTF MEDIUM
K011573 · MQL
Conception Technologies
Obstetrics & Gynecology · 42d
Cleared Jul 02, 2001
PLUS CANCELLOUS BONE SCREWS
K011719 · HWC
Plus Orthopedics
Orthopedic · 28d
Cleared Jul 02, 2001
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
K011740 · MML
Meddev Corp.
Ophthalmic · 27d
Cleared Jul 02, 2001
AGILENT M2636B TELEMON B MONITOR (TELEMON B)
K011824 · DSI
Agilent Technologies, Inc.
Cardiovascular · 21d
Cleared Jul 02, 2001
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
K011920 · KXT
Syva Co., Dade Behring, Inc.
Toxicology · 12d
Cleared Jul 02, 2001
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · LEG
Syva Co.
Toxicology · 11d