Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
140641–140664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1987
FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339
K871284 · JIY
American Research Products Co.
Chemistry · 8d
Cleared Apr 08, 1987
GRAM IODINE
K871286 · HYI
Remel Co.
Pathology · 8d
Cleared Apr 07, 1987
MODIFICATION OF ACCU-CHEK II
K863481 · CGA
Boehringer Mannheim Corp.
Chemistry · 210d
Cleared Apr 07, 1987
FIBERBOND
K864376 · DYT
Dentec, Inc.
Dental · 153d
Cleared Apr 07, 1987
LIGHT-CURED PERIODONTAL DRESSING
K864720 · EMA
Dentsply Intl.
Dental · 125d
Cleared Apr 07, 1987
TRIGLYCERIDES DETERMINATION
K871122 · CDT
Biochemical Trade, Inc.
Chemistry · 18d
Cleared Apr 07, 1987
CUSTOM IN-THE-EAR HEARING AID
K871205 · ESD
Audiological Services, Inc.
Ear, Nose, Throat · 13d
Cleared Apr 07, 1987
HAND SURGERY TABLE EXTENSION
K871225 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 11d
Cleared Apr 06, 1987
CONTAC CASE
K863846 · LPN
S. M. C. Medi-Tech Corp.
Ophthalmic · 187d
Cleared Apr 06, 1987
MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.
K870149 · GEI
Radionics, Inc.
General & Plastic Surgery · 83d
Cleared Apr 06, 1987
CAPILLARY FLOW DIALYZERS
K870169 · FJI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 82d
Cleared Apr 06, 1987
MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM
K870249 · LYX
Bioclinical Laboratory Services, Inc.
Ophthalmic · 75d
Cleared Apr 06, 1987
MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM
K870250 · LYX
Bioclinical Laboratory Services, Inc.
Ophthalmic · 75d
Cleared Apr 06, 1987
CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM
K870251 · LYX
Bioclinical Laboratory Services, Inc.
Ophthalmic · 75d
Cleared Apr 06, 1987
LP EXTENSION SETS
K870416 · FPK
North Coast Medi-Tek
General Hospital · 62d
Cleared Apr 06, 1987
GALAXY POWERED WHEELCHAIR
K870532 · ITI
Global Research, Inc.
Physical Medicine · 59d
Cleared Apr 06, 1987
PHACOTRON DAY PAK
K870671 · HQC
United Surgical Corp.
Ophthalmic · 46d
Cleared Apr 06, 1987
LIQUID CHEMISTRY CONTROL, LEVEL II
K870683 · JJY
U. S. Diagnostics, Inc.
Chemistry · 46d
Cleared Apr 06, 1987
LIQUID CHEMISTRY CONTROL, LEVEL I
K870684 · JJY
U. S. Diagnostics, Inc.
Chemistry · 46d
Cleared Apr 06, 1987
HERCON ANTI. TRANS. DRESSING AS A WOUND DRESSING
K870743 · FRO
Hercon Laboratories Corp.
General & Plastic Surgery · 55d
Cleared Apr 06, 1987
VIBRACARE
K870939 · ISA
General Physiotherapy, Inc.
Physical Medicine · 28d
Cleared Apr 06, 1987
SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)
K871058 · JJY
Fisher Scientific Co., LLC
Chemistry · 20d
Cleared Apr 06, 1987
MODIFIED HYSTEROSALPINGOGRAPY SET
K871069 · KNA
Ackrad Laboratories
Obstetrics & Gynecology · 19d
Cleared Apr 06, 1987
MODIFIED TOWNLEY UNICONDYLAR KNEE
K871118 · KYK
Depuy, Inc.
Orthopedic · 18d