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
49561–49584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 2010
TAPERLOC COMPLETE
K101086 · KWA
Biomet, Inc.
Orthopedic · 137d
Cleared Sep 03, 2010
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED),...
K101186 · DTP
Medtronic Perfusion Systems
Cardiovascular · 128d
Cleared Sep 03, 2010
BIOGRAPH MCT FAMILY
K101550 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Sep 03, 2010
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL,...
K101593 · FYA
Exact Medical Manufacturing, Inc.
General Hospital · 87d
Cleared Sep 03, 2010
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH...
K101799 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 67d
Cleared Sep 03, 2010
3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
K101834 · DRG
3M Company
Cardiovascular · 64d
Cleared Sep 03, 2010
ECLIPSE TREATMENT PLANNING SYSTEM
K102011 · MUJ
Varian Medical Systems, Inc.
Radiology · 49d
Cleared Sep 03, 2010
OSSTAPLE CHILL
K102107 · JDR
Biomedical Ent., Inc.
Orthopedic · 38d
Cleared Sep 03, 2010
CRUISER 18 GUIDEWIRE
K102211 · DQX
Brivant, Ltd.
Cardiovascular · 29d
Cleared Sep 02, 2010
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
K091969 · NBO
Euroimmun Us, Inc.
Immunology · 428d
Cleared Sep 02, 2010
EUROIMMUN ANTI-M2-3E ELISA (IGG)
K092736 · DBM
Euroimmun Us, Inc.
Immunology · 363d
Cleared Sep 02, 2010
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE,...
K093430 · KWS
Exactech, Inc.
Orthopedic · 303d
Cleared Sep 02, 2010
QUINTEX CERVICAL PLATING SYSTEM
K100243 · KWQ
Aesculap Implant Systems, LLC
Orthopedic · 218d
Cleared Sep 02, 2010
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
K100795 · KTT
Smith & Nephew, Inc.
Orthopedic · 164d
Cleared Sep 02, 2010
NIOX MINO MODEL 09-1000
K101034 · MXA
Aerocrine AB
Chemistry · 141d
Cleared Sep 02, 2010
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
K101130 · MNS
Respironics, Inc.
Anesthesiology · 133d
Cleared Sep 02, 2010
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
K101310 · OVD
Theken Spine, LLC
Orthopedic · 114d
Cleared Sep 02, 2010
NMI IC
K101326 · LJS
Navilyst Medical, Inc.
General Hospital · 114d
Cleared Sep 02, 2010
SHARPS CONTAINER
K101567 · MMK
Cixi Leinuo Plastic Co., Ltd.
General Hospital · 90d
Cleared Sep 02, 2010
EASY TOUCH
K102178 · FMF
Mhc Medical Products
General Hospital · 30d
Cleared Sep 01, 2010
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
K101506 · ONG
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 92d
Cleared Sep 01, 2010
NESSI OTC SPACER
K101532 · NVO
Pharmacaribe
Anesthesiology · 90d
Cleared Sep 01, 2010
VITAL SIGNS MONITOR
K101602 · MLD
Criticare Systems, Inc.
Cardiovascular · 85d
Cleared Sep 01, 2010
NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
K101860 · MQV
Novabone Products, LLC
Orthopedic · 61d