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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
159841–159864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1982
MODEL #2000 HI-TEMP & #3000 LOW-TEMP
K822513 · GEI
Surgicare Scientific Laboratory, Inc.
General & Plastic Surgery · 32d
Cleared Sep 21, 1982
CSM BETA-LACTAMASE DISC
K822518
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 29d
Cleared Sep 21, 1982
POLYHESIVE PATIENT RETURN ELECTRODE
K822572 · GEI
Valleylab, Inc.
General & Plastic Surgery · 28d
Cleared Sep 21, 1982
QUIKPAGE SCANNER
K822582 · DPS
Agilent Technologies
Cardiovascular · 27d
Cleared Sep 21, 1982
ADVANCE EMIT-CAD QUINIDINE CONTROL
K822587 · DLJ
Syva Co.
Toxicology · 26d
Cleared Sep 21, 1982
VERTEX PERCUTANEOUS PUNCTURE NEEDLE
K822596 · DQO
Vertex Medical Corp.
Cardiovascular · 25d
Cleared Sep 21, 1982
GUIDE WIRE
K822597 · DQX
Vertex Medical Corp.
Cardiovascular · 25d
Cleared Sep 21, 1982
BLOOD PRESSURE MONITORING DEVICES
K822614 · DXN
Allied Healthcare Products, Inc.
Cardiovascular · 22d
Cleared Sep 21, 1982
LIFE WATCH LSI
K822615 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 22d
Cleared Sep 21, 1982
RIWOLITH 2135
K822644 · FFK
R. Wolf Medical Instruments Corp.
Gastroenterology & Urology · 20d
Cleared Sep 21, 1982
YERSINIA AGAR BASE & SUPPLEMENT
K822659 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
VOGEL JOHNSON AGAR
K822660 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
RAPID REAGIN CARD TEST
K822661 · GMQ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
REAGIN ANTIGEN SUSPENSION
K822662 · GMQ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
FEBRILE ANTIGEN KIT
K822663 · GSO
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
PSEUDOMONAS AGAR BASE, C-N & C-F-C SUPP
K822664 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
WILKINS-CHALGREN ANAEROBE BROTH
K822665 · JSC
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY
K822685 · BTI
Certified Respiratory Services, Inc.
Anesthesiology · 18d
Cleared Sep 21, 1982
DENVER PERITONEO-VENOUS SHUNT (DP-VS)
K822686 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 18d
Cleared Sep 21, 1982
ACU-MASSAGE TABLE
K822693 · JFB
H.W.E., Inc.
Physical Medicine · 14d
Cleared Sep 17, 1982
ENT MALLETS
K822204 · GFJ
Kelleher Corp.
General & Plastic Surgery · 56d
Cleared Sep 17, 1982
COMPLY NEUROMUSCULAR STIMULATOR
K822284 · IPF
Omega-Med Intl., Inc.
Physical Medicine · 49d
Cleared Sep 17, 1982
ROMBEAU GASTROSTOMY-JEJUNAL TUBE
K822380 · KNT
Hedeco
Gastroenterology & Urology · 39d
Cleared Sep 17, 1982
CREST PRESSURE INFUSOR
K822434 · KZD
Crest Medical Equipment
General Hospital · 35d