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
167665–167688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1980
PERITONE
K800191 · HIR
Laurie Ann Kaiser, Ph.D.
Gastroenterology & Urology · 78d
Cleared Apr 16, 1980
USCI BIPOLAR BALLON PACING ELECTRODE
K800298 · LDF
C.R. Bard, Inc.
Cardiovascular · 65d
Cleared Apr 16, 1980
HEMOSAFE
K800346 · GKL
Med Lab Systems, Inc.
Hematology · 61d
Cleared Apr 16, 1980
BI-LEVEL ASSAYED CARD. DRUG CONT., I,II
K800357 · LAS
Ortho Diagnostics, Inc.
Toxicology · 56d
Cleared Apr 16, 1980
Y-TYPE INFUSION SET (2 LEAD)
K800358 · FPA
Haemonetics Corp.
General Hospital · 56d
Cleared Apr 16, 1980
NOMOS-01 PULSE GENERATOR
K800375 · DXY
Biotronik Sales, Inc.
Cardiovascular · 55d
Cleared Apr 16, 1980
MCGAW/EPIC I.V. ADMIN. SET
K800403 · FPA
American Hospital Supply Corp.
General Hospital · 50d
Cleared Apr 16, 1980
STEAROTHERMOHILUS SPORE STRIPS
K800482 · FRC
Mdt Corp., Inc.
General Hospital · 43d
Cleared Apr 16, 1980
SURGERY DISPLAY SYSTEM
K800488 · DRQ
Kent Barker & Assoc.
Cardiovascular · 43d
Cleared Apr 16, 1980
SHIELD LUCKY CAP
K800511 · FYF
American Convertors Div., American...
General & Plastic Surgery · 42d
Cleared Apr 16, 1980
SHIELD PERFECT FIT
K800528 · FXP
American Convertors Div., American...
General Hospital · 40d
Cleared Apr 16, 1980
SNYDER HYSTERECTOMY Y TUBE KIT
K800543 · GCY
Snyder Laboratories, Inc.
General & Plastic Surgery · 37d
Cleared Apr 16, 1980
HEPARIN PUMP #7420
K800570 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 33d
Cleared Apr 16, 1980
SNYDER HEMOVAC TM VENTED WOUND KIT
K800577 · GCY
Snyder Laboratories, Inc.
General & Plastic Surgery · 33d
Cleared Apr 16, 1980
SURGIVAC TM
K800578 · GCY
Snyder Laboratories, Inc.
General & Plastic Surgery · 33d
Cleared Apr 16, 1980
B-D STASET, I.V. FLOW CONTROLLER
K800600 · FPA
Bd Becton Dickinson Vacutainer...
General Hospital · 30d
Cleared Apr 16, 1980
MICROMEDIC AUTOMATIC DILUTER
K800606 · JQW
Micromedic Systems
Chemistry · 30d
Cleared Apr 16, 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-02
K800644 · DXY
Intermedics, Inc.
Cardiovascular · 23d
Cleared Apr 16, 1980
NORSEN DEBRIDER
K800647 · GEN
Medline Industries, Inc.
General & Plastic Surgery · 23d
Cleared Apr 16, 1980
MODEL 100 SPECTRAVIEW
K800655 · DQC
Edwards Laboratories
Cardiovascular · 22d
Cleared Apr 16, 1980
FERRITIN CONTROLS CODE QAS.104
K800657 · DBF
Amersham Corp.
Immunology · 22d
Cleared Apr 16, 1980
RST-SERIES CONTROL
K800658 · KSF
Gamma Biologicals, Inc.
Microbiology · 21d
Cleared Apr 16, 1980
MONITEMP BLOOD PACK TEMP. MONITOR
K800667 · KSE
Liquid Crystal Products, Inc.
Hematology · 21d
Cleared Apr 16, 1980
SMAC REPLACEMENT REAGENTS, WETTING AGENT
K800670
Diagnostic Solutions, Inc.
Chemistry · 21d