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

133489–133512 of 175,820

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

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

Cleared Dec 21, 1988

BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET

Bio Medicus, Inc.

Cardiovascular · 82d

Cleared Dec 21, 1988

USCI DORROS INFUSION/PROBING CATHETER

Usci, Div. C.R. Bard, Inc.

Cardiovascular · 76d

Cleared Dec 21, 1988

ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE

Advanced Cardiovascular Systems, Inc.

Cardiovascular · 71d

Cleared Dec 21, 1988

INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER

Medtronic Blood Systems, Inc.

Cardiovascular · 64d

Cleared Dec 21, 1988

MT/S (SOFTWARE RELEASE 3.1)

Diasonics, Inc.

Radiology · 47d

Cleared Dec 20, 1988

AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2

C.I.S.A. Import Export C/O Larson and...

Obstetrics & Gynecology · 313d

Cleared Dec 20, 1988

AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3

C.I.S.A. Import Export C/O Larson and...

Obstetrics & Gynecology · 313d

Cleared Dec 20, 1988

AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4

C.I.S.A. Import Export C/O Larson and...

Obstetrics & Gynecology · 313d

Cleared Dec 20, 1988

ERYTHROPOIETIN ENZYME IMMUNOASSAY

Hematology · 173d

Cleared Dec 20, 1988

MODIFICATION OF MONO-PLUS(TM)

Immunology · 112d