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

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176,076 results

70177–70200 of 176,076

Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery

Cleared Feb 04, 2004

PRESS-MATE BX-10 VITAL SIGN MONITOR

Colin Medical Instruments Corp.

Cardiovascular · 145d

Cleared Feb 04, 2004

HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE

Helica Instruments, Ltd.

General & Plastic Surgery · 134d

Cleared Feb 04, 2004

SIMULIX EVOLUTION

Nucletron Corporation

Radiology · 93d

Cleared Feb 04, 2004

PHOSPHOLIN ES AND CALCIUM CHLORIDE

R2 Diagnostics, Inc.

Hematology · 93d

Cleared Feb 04, 2004

BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM

C.R. Bard, Inc.

Gastroenterology & Urology · 91d

Cleared Feb 04, 2004

MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT

General & Plastic Surgery · 76d

Cleared Feb 04, 2004

POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS

Polymedco, Inc.

Chemistry · 70d

Cleared Feb 04, 2004

BARD TIGERTAIL URETERAL CATHETER

C.R. Bard, Inc.

Gastroenterology & Urology · 70d

Cleared Feb 04, 2004

GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES

Biocompatibles UK Limited

Neurology · 64d

Cleared Feb 04, 2004

MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE

Neurology · 57d

Cleared Feb 04, 2004

THERMAGE THERMACOOL SYSTEM

General & Plastic Surgery · 47d

Cleared Feb 04, 2004

PERIFIX CATHETER CONNECTOR

B.Braun Medical, Inc.

Anesthesiology · 44d

Cleared Feb 04, 2004

ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV...

Ophthalmic · 44d

Cleared Feb 04, 2004

SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055,...

Bacchus Vascular, Inc.

Cardiovascular · 42d

Cleared Feb 04, 2004

SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29

Power Medical Interventions, Inc.

General & Plastic Surgery · 28d

Cleared Feb 04, 2004

CURVED CUTTER STAPLER, MODELS CS40B, CS40G

Ethicon Endo-Surgery, Inc.

General & Plastic Surgery · 27d

Cleared Feb 04, 2004

Medical Products Laboratories, Inc.

Cleared Feb 03, 2004

MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER

Mercury Medical

Anesthesiology · 165d

Cleared Feb 03, 2004

INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

Interlab S.R.L.

Hematology · 144d

Cleared Feb 03, 2004

BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,...

Beckman Coulter, Inc.

Immunology · 127d

Cleared Feb 03, 2004

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

Trek Diagnostic Systems, Inc.

Microbiology · 88d

Cleared Feb 03, 2004

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML

Becton, Dickinson & CO

Microbiology · 61d

Cleared Feb 03, 2004

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT...

Becton, Dickinson & CO

Microbiology · 49d

Cleared Feb 03, 2004

LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)

Bio-Rad Laboratories, Inc.

Chemistry · 47d