FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results

135193–135216 of 175,820

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

Cleared Jul 25, 1988

ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE

Advanced Cardiovascular Systems, Inc.

Cardiovascular · 90d

Cleared Jul 25, 1988

PROFICIENT(TM) PROPHYLAXIS ANGLE

Block Drug Company, Inc.

Cleared Jul 25, 1988

CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP

Cleared Jul 25, 1988

HYCEL QUICK-LYSING HEMOGLOBIN REAGENT

R&D Systems, Inc.

Hematology · 39d

Cleared Jul 25, 1988

E-Z-EM(R) LUFKIN BIOPSY NEEDLES

General & Plastic Surgery · 31d

Cleared Jul 25, 1988

EURO-MED ENDO-CURETTE

Buckman Co., Inc.

Obstetrics & Gynecology · 31d

Cleared Jul 25, 1988

Milex Products, Inc.

Obstetrics & Gynecology · 28d

Cleared Jul 25, 1988

GENERAL SURGICAL TABLE AND ACCESSORIES

American Sterilizer Co.

General & Plastic Surgery · 27d

Cleared Jul 22, 1988

CHANGE TO CATHODE POWDER SPECIFICATION

Telectronics and Cordis Pacing Systems

Cardiovascular · 77d

Cleared Jul 22, 1988

MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE

Medtronic Andover Medical, Inc.

Cardiovascular · 65d

Cleared Jul 22, 1988

CARD GUARD, MODEL CG-2000

Card Guard Scientific Survival , Ltd.

Cardiovascular · 51d

Cleared Jul 22, 1988

CR-39 PLASTIC LENSES FOR EYEGLASSES

Automated Lens System

Ophthalmic · 49d

Cleared Jul 22, 1988

MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004

Tpl-Cordis, Inc.

Cardiovascular · 38d

Cleared Jul 22, 1988

ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA

Baxter Healthcare Corp

Gastroenterology & Urology · 23d

Cleared Jul 21, 1988

DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER

Ferguson Medical

Physical Medicine · 129d

Cleared Jul 21, 1988

DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER

Ferguson Medical

Physical Medicine · 129d

Cleared Jul 21, 1988

AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST

Chemistry · 126d

Cleared Jul 21, 1988

DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER

Cadco Dental Products, Inc.

Cleared Jul 21, 1988

COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE

Nathaniel Gould Diagnostics, Inc.

Physical Medicine · 118d

Cleared Jul 21, 1988

REAGENTS FOR TSH ASSAY

Chemistry · 111d

Cleared Jul 21, 1988

RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR

Rondex Products, Inc.

Anesthesiology · 73d

Cleared Jul 21, 1988

DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023

Diagnostic Chemicals, Ltd. (Usa)

Chemistry · 51d

Cleared Jul 21, 1988

A.X.T. SPOTFILM DEVICE

Applied X-Ray Technologies, Inc.

Radiology · 35d

Cleared Jul 21, 1988

LATEX EXAMINATION GLOVE

General Hospital · 30d