Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
79417–79440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 29, 2001
HOME HEALTH MONITORING SYSTEM
K010029 · DXN
Avid Care Corp.
Cardiovascular · 177d
Cleared Jun 29, 2001
ZURICH DISTRACTION SYSTEM
K010139 · MQN
KLS-Martin L.P.
Dental · 163d
Cleared Jun 29, 2001
LIPOMATIC
K010311 · QPB
Euromi S.A
General & Plastic Surgery · 148d
Cleared Jun 29, 2001
THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM
K010692 · FMF
Spintech, Inc.
General Hospital · 113d
Cleared Jun 29, 2001
TRAM 2001 MODULE
K011000 · MHX
General Electric Medical Systems...
Cardiovascular · 87d
Cleared Jun 29, 2001
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011375 · GAM
Aesculap, Inc.
General & Plastic Surgery · 56d
Cleared Jun 29, 2001
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
K011394 · EIH
Espe Dental AG
Dental · 53d