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

70681–70704 of 175,468

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

Cleared Oct 09, 2003

REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD...

American I.V. Products, Inc.

General Hospital · 31d

Cleared Oct 09, 2003

US-100 PORTABLE ULTRASOUND THERAPY UNIT

Physical Medicine · 30d

Cleared Oct 09, 2003

Medical Analysis Systems, Inc.

Toxicology · 29d

Cleared Oct 09, 2003

UNOMEDICAL MONICA INFUSION SET

General Hospital · 27d

Cleared Oct 09, 2003

T2 RECON NAIL SYSTEM

Howmedica Osteonics Corp.

Orthopedic · 22d

Cleared Oct 09, 2003

SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES

Cleared Oct 08, 2003

CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

Roche Diagnostics Corp.

Chemistry · 62d

Cleared Oct 08, 2003

METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING

Meta Biomed Co., Ltd.

Cleared Oct 08, 2003

ENDOTINE FOREHEAD DEVICE

Coapt Systems, Inc.

Orthopedic · 30d

Cleared Oct 08, 2003

MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO...

Hill-Rom Manufacturing, Inc.

Obstetrics & Gynecology · 30d

Cleared Oct 08, 2003

GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM

Ge Medical Systems, LLC

Radiology · 30d

Cleared Oct 08, 2003

WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A

Wide Corporation

Radiology · 15d

Cleared Oct 07, 2003

DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS

Datex-Ohmeda, Inc.

Anesthesiology · 364d

Cleared Oct 07, 2003

NICO WITH MARS, MODEL 7300

Respironics Novametrix, Inc.

Anesthesiology · 200d

Cleared Oct 07, 2003

3M LIQUID BANDAGE, MODEL 120-LB

General & Plastic Surgery · 169d

Cleared Oct 07, 2003

VIGORMIST COMPRESSOR NEBULIZER

Vega Technologies, Inc.

Anesthesiology · 155d

Cleared Oct 07, 2003

Medical Scientific, Inc.

General & Plastic Surgery · 141d

Cleared Oct 07, 2003

I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3

I-Stat Corporation

Chemistry · 112d

Cleared Oct 07, 2003

BETEC RETRACTABLE SAFETY SYRINGE (5ML)

Betec Medical Science Co., Ltd.

General Hospital · 109d

Cleared Oct 07, 2003

ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE,...

Orthopedic · 91d

Cleared Oct 07, 2003

NUVASIVE CEMENT RESTRICTOR

Orthopedic · 82d

Cleared Oct 07, 2003

DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT

Cleared Oct 07, 2003

BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW

Long First (Xiamen) Plastics Co., Ltd.

General Hospital · 71d

Cleared Oct 07, 2003

JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE

Js Vascular, Inc.

Cardiovascular · 63d