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
51097–51120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K093798 · LYZ
Supermax Plastic Products Co., Ltd.
General Hospital · 75d
Cleared Feb 23, 2010
CORVUS RADIATION THERAPY PLANNING SYSTEM
K100092 · MUJ
Best Nomos
Radiology · 41d
Cleared Feb 23, 2010
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
K100107 · OLO
Smith & Nephew, Inc.
Orthopedic · 40d
Cleared Feb 23, 2010
SAS FLUALERT A&B, SAS INFLUENZA A TEST
K100227 · PSZ
Sa Scientific, Inc.
Microbiology · 28d
Cleared Feb 22, 2010
NATUS NEUROWORKS, MODEL 104196
K090019 · OMB
Natus Medical, Inc.
Neurology · 416d
Cleared Feb 22, 2010
CAPILLARYS NEONAT HB (PN 2006)
K091283 · GKA
Sebia
Hematology · 297d
Cleared Feb 22, 2010
POGO SCREW INSTRUMENTATION TRAY
K091806 · KCT
Fxdevices
General Hospital · 249d
Cleared Feb 22, 2010
BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE...
K092144 · ESW
Endochoice, Inc.
Gastroenterology & Urology · 222d
Cleared Feb 22, 2010
BACT-TRAP HEPA MIDI
K093426 · CAH
Pharma Systems AB
General Hospital · 111d
Cleared Feb 22, 2010
ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
K093718 · FCY
Zutron Medical, LLC
Gastroenterology & Urology · 82d
Cleared Feb 22, 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY...
K093726 · LZA
Medline Industries, Inc.
General Hospital · 81d
Cleared Feb 22, 2010
ALTERA NEBULIZER SYSTEM, MODEL 678G1002
K100380 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 6d
Cleared Feb 19, 2010
SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K090917 · LHI
Baxa Corp.
General Hospital · 324d
Cleared Feb 19, 2010
HAMMERLOCK
K091951 · HTY
Biomedical Ent., Inc.
Orthopedic · 233d
Cleared Feb 19, 2010
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
K092295 · KWP
Pioneer Surgical Technology
Orthopedic · 205d
Cleared Feb 19, 2010
ACCELERATOR APS
K093318 · CEM
Abbott Laboratories
Chemistry · 119d
Cleared Feb 19, 2010
ELI PC ELECTROCARDIOGRAPH
K093339 · DPS
Mortara Instrument, Inc.
Cardiovascular · 116d
Cleared Feb 19, 2010
FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING...
K093712 · NBW
Taidoc Technology Corporation
Chemistry · 79d
Cleared Feb 19, 2010
COSP2
K093721 · MVL
3M Espe AG Dental Products
Dental · 79d
Cleared Feb 19, 2010
MULTIPLE NAME MODEL MULTIPLE
K093759 · LZA
Gx Corporation Sdn Bhd (Plant 1)
General Hospital · 74d
Cleared Feb 19, 2010
INTOUCH DIABETES
K093789 · NBW
Symcare Personalized Health...
Chemistry · 72d
Cleared Feb 19, 2010
NUVASIVE HELIX REVOLUTION ACP SYSTEM
K093804 · KWQ
Nuvasive, Inc.
Orthopedic · 70d
Cleared Feb 19, 2010
OSCAR 3
K093805 · JDX
Orthosonics, Ltd.
Orthopedic · 70d
Cleared Feb 19, 2010
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
K100197 · HSX
Smith & Nephew, Inc.
Orthopedic · 28d