FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

175,230 results

132889–132912 of 175,230

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

Cleared Dec 22, 1988

ORTHO* SYPHILIS-G ANTIBODY ELISA TEST

Ortho Diagnostic Systems, Inc.

Microbiology · 94d

Cleared Dec 22, 1988

HEMORX COLD PACK

Gastroenterology & Urology · 93d

Cleared Dec 22, 1988

PMT MODEL 1110-5 PMT PERITONEAL CATHETER

Neurology · 87d

Cleared Dec 22, 1988

INDENTEC DRILL RA #1

Phillip C. Crawford, D.D.S.

Cleared Dec 22, 1988

Ticomet Engineering & Consulting

Cleared Dec 22, 1988

FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT

Abbott Laboratories

Gastroenterology & Urology · 71d

Cleared Dec 22, 1988

J. Morita USA, Inc.

Cleared Dec 22, 1988

MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET

General Hospital · 71d

Cleared Dec 22, 1988

MODEL WC-107 MOBILE NEWBORN BED

General Hospital · 71d

Cleared Dec 22, 1988

MODEL WC-115 MOBILE BASSINET

General Hospital · 71d

Cleared Dec 22, 1988

OCCLUSAL HARMONY IMPRESSION TRAY

Advantage Dental Co.

Cleared Dec 22, 1988

ADAC VIEWPOINT (ADDITIONAL SOFTWARE)

Adac Laboratories

Radiology · 71d

Cleared Dec 22, 1988

SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED

Scientific Pharmaceuticals, Inc.

Cleared Dec 22, 1988

LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE

Toxicology · 64d

Cleared Dec 22, 1988

COTUBE LH IRMA ASSAY

Chemistry · 57d

Cleared Dec 22, 1988

BOVAC SMOKE COLLECTOR

Orthopedic Systems, Inc.

General & Plastic Surgery · 45d

Cleared Dec 22, 1988

GROUP A STREP, BETA-STREP

Microbiology · 38d

Cleared Dec 22, 1988

SLT CLMD CONTACT LASER

Surgical Laser Technologies, Inc.

Anesthesiology · 35d

Cleared Dec 22, 1988

Medical Action Industries, Inc.

General & Plastic Surgery · 34d

Cleared Dec 22, 1988

COMPAX MODEL 40, 400, 400T

General Electric Co.

Radiology · 27d

Cleared Dec 22, 1988

SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD

Sony Medical Electronics Co.

General & Plastic Surgery · 17d

Cleared Dec 21, 1988

CMS RECORD AND VERIFY SYSTEM

Computerized Medical Systems, Inc.

Radiology · 189d

Cleared Dec 21, 1988

VARIABLE KV INTREX VSK 60 - 90 KVP

Keystone X-Ray, Inc.

Radiology · 134d

Cleared Dec 21, 1988

USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR

C.R. Bard, Inc.

Cardiovascular · 83d