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

Filters: Cleared only ×
175,820 results
146761–146784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1985
PALL PULMONARY FUNCTION FILTER
K854062 · BZG
Pall Biomedical Products Co.
Anesthesiology · 34d
Cleared Nov 06, 1985
LAP-CATH
K852197 · DQO
Research Medical, Inc.
Cardiovascular · 170d
Cleared Nov 06, 1985
NOVAMETRIX PULSE OXIMETER, MODEL 500
K853124 · JOM
Novametrix Medical Systems, Inc.
Cardiovascular · 104d
Cleared Nov 06, 1985
NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8
K853134 · FRN
Erika, Inc.
General Hospital · 103d
Cleared Nov 06, 1985
MEDTRONIC ACCESS PORT MODEL 8500
K853322 · LJT
Medtronic Vascular
General Hospital · 90d
Cleared Nov 06, 1985
DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY
K853513 · FKP
Cd Medical, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 06, 1985
SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST
K853830 · LHI
Travenol Laboratories, S.A.
General Hospital · 54d
Cleared Nov 06, 1985
MVM 4000 HOLTER IV RECORDER
K853985 · DSH
Mountain View Medical
Cardiovascular · 40d
Cleared Nov 06, 1985
GUIDING CATHETER
K853998 · DQY
Target Therapeutics
Cardiovascular · 37d
Cleared Nov 06, 1985
SNAP-LOCK ADDITIVE CAP #SL100
K854031 · KPE
Williams Medical Co.
General Hospital · 36d
Cleared Nov 06, 1985
SNAP-LOCK ADDITIVE CAP #SL400
K854033 · KPE
Williams Medical Co.
General Hospital · 36d
Cleared Nov 06, 1985
SNAP-LOCK ADDITIVE CAP #SL 300
K854034 · KPE
Williams Medical Co.
General Hospital · 36d
Cleared Nov 06, 1985
I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC
K854171 · FTC
Intl. Solarium Manufacturer, Inc.
General & Plastic Surgery · 22d
Cleared Nov 05, 1985
ENZYGNOST ANTIHERPES SIMPLEX VIRUS
K841245 · GQO
Behring Diagnostics, Inc.
Immunology · 592d
Cleared Nov 05, 1985
EMERGIPACE - EXTERNAL PACEMAKER
K850812 · DRO
Life Science Instrumentation, Inc.
Cardiovascular · 250d
Cleared Nov 05, 1985
COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE
K851153 · JPA
Astral Medical Systems
Hematology · 228d
Cleared Nov 05, 1985
FLEXISTAND MAJOR
K852152
Zygotek Assoc.
Physical Medicine · 172d
Cleared Nov 05, 1985
URI-CATH SYSTEM
K852490 · KNX
Gesco Intl., Inc.
Gastroenterology & Urology · 146d
Cleared Nov 05, 1985
7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS
K852791 · DQY
Cardio-Vascular Innovations, Inc.
Cardiovascular · 127d
Cleared Nov 05, 1985
COMFORT + LIFT
K852812 · INO
Invacare Corp.
Physical Medicine · 126d
Cleared Nov 05, 1985
CR 280/45, CR281/4 DEFIBRILLATOR
K852905 · LDD
Cardiac Recorders, Ltd.
Cardiovascular · 119d
Cleared Nov 05, 1985
ROTACLONE ROTAVIRUS DIAGNOSTIC KIT
K852969 · LIQ
Cambridge Bioscience Corp.
Microbiology · 113d
Cleared Nov 05, 1985
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
K853036 · GKL
Diagnostic Technology, Inc.
Hematology · 110d
Cleared Nov 05, 1985
SETMA VHT
K853163 · ILJ
Setma, Inc.
Physical Medicine · 98d