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

71953–71976 of 175,468

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

Cleared Jun 02, 2003

CRP (II) CALIBRATORS

Denka Seiken Co., Ltd.

Immunology · 102d

Cleared Jun 02, 2003

PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX

Karl Storz Endoscopy

Orthopedic · 77d

Cleared Jun 02, 2003

GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)

Dade Behring, Inc.

Chemistry · 54d

Cleared Jun 02, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE

Becton, Dickinson & CO

Microbiology · 39d

Cleared Jun 02, 2003

ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY

Beckman Coulter, Inc.

Microbiology · 19d

Cleared May 30, 2003

VAPOTHERM 2000H

Vapotherm, Inc.

Anesthesiology · 588d

Cleared May 30, 2003

SPECTRUM SILICONE CATHETER

General Hospital · 382d

Cleared May 30, 2003

INION OTPS BIODEGRADABLE MINI PLATING SYSTEM

Orthopedic · 190d

Cleared May 30, 2003

EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP

S-Tct Health, Inc.

Cardiovascular · 94d

Cleared May 30, 2003

FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON...

X-Cel Contacts, A Walman Co.

Ophthalmic · 94d

Cleared May 30, 2003

STRYKER PAINPUMP2

Stryker Instruments

General Hospital · 88d

Cleared May 30, 2003

GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING

Gish Biomedical, Inc.

Cardiovascular · 84d

Cleared May 30, 2003

PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES...

Primary Care Solutions, Inc.

Gastroenterology & Urology · 77d

Cleared May 30, 2003

MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)

Medtronic Ave, Inc.

Gastroenterology & Urology · 74d

Cleared May 30, 2003

Cleared May 30, 2003

Cleared May 30, 2003

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)

Disc-O-Tech Medical Technologies, Ltd.

Orthopedic · 63d

Cleared May 30, 2003

CAREO RETRACTABLE SAFETY SYRINGE

Life-Shield Products, Inc.

General Hospital · 63d

Cleared May 30, 2003

MSI SA ELECTRODES

Medsphere International, Inc.

General & Plastic Surgery · 60d

Cleared May 30, 2003

SYS*STIM 208 AND 208A

Mettler Electronics Corp.

Physical Medicine · 60d

Cleared May 30, 2003

SURSHIELD SAFETY WINGED INFUSION SET

General Hospital · 39d

Cleared May 30, 2003

SURSHIELD SAFETY WINGED BLOOD COLLECTION SET

Terumo Medical Products Hangzhou Co.,...

General Hospital · 38d

Cleared May 30, 2003

LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND...

General Hospital · 99d

Cleared May 30, 2003

MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3

Medical Analysis Systems, Inc.

Chemistry · 30d