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
142177–142200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1986
TRAVELER LT
K862690 · GWF
Bio-Logic Systems Corp.
Neurology · 133d
Cleared Nov 25, 1986
7.5 MHZ LINEAR PROBE, CAT. NO. H4221H
K862844 · ITX
General Electric Co.
Radiology · 119d
Cleared Nov 25, 1986
D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM
K863230 · DXG
Dextra Medical, Inc.
Cardiovascular · 96d
Cleared Nov 25, 1986
D100 COMPUTER CARDIAC ANALYSIS SYSTEM
K863231 · DXG
Dextra Medical, Inc.
Cardiovascular · 96d
Cleared Nov 25, 1986
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
K863476 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Nov 25, 1986
DERMATEC ZONE TRANSPARENT DRESSING
K863578 · NAD
Dermatec, Inc.
General & Plastic Surgery · 89d
Cleared Nov 25, 1986
ESOPHAGEAL RECTAL TEMPERATURE PROBE
K863646 · FLL
Respiratory Support Products, Inc.
General Hospital · 68d
Cleared Nov 25, 1986
STERILIZATION WRAPS #620,624,648,640,636,630,612
K863981 · FRG
Graham Medical Products
General Hospital · 42d
Cleared Nov 25, 1986
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
K864041 · KLS
Em Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Nov 25, 1986
ANAGO ISOLATION MASK (#80-950)
K864116 · LGM
Anago, Inc.
General Hospital · 35d
Cleared Nov 25, 1986
IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY
K864213 · LGP
Instrumentation Laboratory CO
Hematology · 28d
Cleared Nov 25, 1986
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
K864214 · JBQ
Instrumentation Laboratory CO
Hematology · 28d
Cleared Nov 25, 1986
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA
K864271 · JPA
Instrumentation Laboratory CO
Hematology · 27d
Cleared Nov 25, 1986
OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE
K864372
Osteonics Corp.
Orthopedic · 20d
Cleared Nov 25, 1986
SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1
K864506 · DSI
Spacelabs, Inc.
Cardiovascular · 11d
Cleared Nov 25, 1986
LP ARTHROSCOPIC THIGH HOLDING DEVICE
K864513 · HRX
Twin Falls Orthopedic Associates, P.A.
Orthopedic · 12d
Cleared Nov 24, 1986
HAYES VAGINAL SHIELD
K862478 · HDF
Franklin Medical USA, Inc.
Obstetrics & Gynecology · 147d
Cleared Nov 24, 1986
MIDDLE EAR VIEWER AND FLUID COLLECTOR
K862903 · JZF
Steven K. Juhn
Ear, Nose, Throat · 116d
Cleared Nov 24, 1986
AMR RESEARCH TONOMETER
K862958 · LCH
Associated Medical Representatives
Chemistry · 111d
Cleared Nov 24, 1986
BILIRUBIN TOTAL
K863056 · CIG
J. D. Assoc.
Chemistry · 104d
Cleared Nov 24, 1986
GLUCOMETER-E
K863102 · CGA
J. D. Assoc.
Chemistry · 103d
Cleared Nov 24, 1986
FERROFAST
K863109 · JIY
J. D. Assoc.
Chemistry · 103d
Cleared Nov 24, 1986
7.5 MHZ LINEAR SMALL PARTS PROBE
K863338 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Nov 24, 1986
MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA
K863361 · HHR
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 83d