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
52297–52320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2009
PRO-PICC CT
K092347 · LJS
Medcomp
General Hospital · 43d
Cleared Sep 16, 2009
POWDERED VINYL PATIENT EXAMINATION GLOVES
K092416 · LYZ
Shijiazhuang Elegance Plastic Product
General Hospital · 41d
Cleared Sep 16, 2009
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · CFR
Medica Corp.
Chemistry · 30d
Cleared Sep 16, 2009
ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX,...
K092594 · DZE
Ace Surgical Supply Co., Inc.
Dental · 23d
Cleared Sep 15, 2009
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
K081996 · FGE
Flexible Stenting Solutions, Inc.
Gastroenterology & Urology · 428d
Cleared Sep 15, 2009
BELTBEAT WF-400
K083715 · DPS
Bonus Communicaciones Srl
Cardiovascular · 274d
Cleared Sep 15, 2009
ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
K091117 · KXK
Isoaid, LLC
Radiology · 151d
Cleared Sep 15, 2009
ESTECH HAWKEYE INTRODUCER SYSTEMS
K091350 · GCJ
Endoscopic Technologies, Inc. D/B/A...
General & Plastic Surgery · 131d
Cleared Sep 15, 2009
MODEL 1014 PC ELECTROMETER
K092019 · IYE
Sun Nuclear Corp.
Radiology · 71d
Cleared Sep 15, 2009
STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)
K092134 · LLZ
Statrad, LLC
Radiology · 62d
Cleared Sep 15, 2009
ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K092304 · KGO
Cardinal Health, Inc.
General Hospital · 48d
Cleared Sep 15, 2009
FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES
K092533 · GAT
Beere Precision Medical Instruments,...
General & Plastic Surgery · 27d
Cleared Sep 15, 2009
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 /...
K092577 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 25d
Cleared Sep 15, 2009
QUICKVUE INFLUENZA A+B TEST
K092698 · PSZ
Quidel Corp.
Microbiology · 13d
Cleared Sep 14, 2009
GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW
K083567 · MNH
Co-Ligne AG
Orthopedic · 285d
Cleared Sep 14, 2009
TSI
K090174 · DZE
Oco Biomedical
Dental · 234d
Cleared Sep 14, 2009
RUTTER SUPRA STOMAL STENTS
K091135 · FWN
Boston Medical Products, Inc.
Ear, Nose, Throat · 147d
Cleared Sep 14, 2009
GRACE DYNAMIC TORP
K091187 · ETA
Grace Medical, Inc.
Ear, Nose, Throat · 144d
Cleared Sep 14, 2009
FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C
K091488 · LJS
Footprint Medical
General Hospital · 118d
Cleared Sep 14, 2009
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
K091638 · MAX
Spinefrontier, Inc.
Orthopedic · 102d
Cleared Sep 14, 2009
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
K091968 · FCW
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Sep 14, 2009
MODIFICATION TO: PSS SYSTEM
K092128 · MNI
Spinal USA
Orthopedic · 61d
Cleared Sep 11, 2009
URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE...
K082811 · JIO
Urit Medical Electronic Co., Ltd.
Chemistry · 352d
Cleared Sep 11, 2009
DENSICHEK PLUS
K083536 · LON
bioMerieux, Inc.
Microbiology · 287d