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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
53449–53472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 2009
PERCUCATH URINARY CATHETER
K090262 · EZL
Percuvision, LLC
Gastroenterology & Urology · 114d
Cleared May 28, 2009
DEXIS SENSOR
K090458 · MUH
Dexis, LLC
Radiology · 94d
Cleared May 28, 2009
DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS...
K090528 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared May 28, 2009
CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS
K090602 · DSB
Cardiodynamics International Corp.
Cardiovascular · 84d
Cleared May 28, 2009
IMMUNOCARD STAT CAMPY, MODEL 751530
K090700 · LQP
Meridian Bioscience, Inc.
Microbiology · 72d
Cleared May 28, 2009
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
K090957 · GWL
I2s Micro Implantable Systems, LLC
Neurology · 52d
Cleared May 28, 2009
DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES
K090979 · GCJ
Encision, Inc.
General & Plastic Surgery · 51d
Cleared May 28, 2009
ECSCOPE 100
K091358 · DPS
Dyansys, Inc.
Cardiovascular · 20d
Cleared May 27, 2009
REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1
K082419 · MQV
Intra-Lock International, Inc.
Orthopedic · 278d
Cleared May 27, 2009
FLUID FILLED TEETHER
K082824 · KKO
Kids II
Dental · 244d
Cleared May 27, 2009
EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER
K082858 · FQH
Alcavis International, Inc.
General Hospital · 240d
Cleared May 27, 2009
SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
K083118 · ODP
Spinal USA
Orthopedic · 217d
Cleared May 27, 2009
NEUROMETRIX BIOAMPLIFIER
K083322 · GWL
Neurometrix, Inc.
Neurology · 196d
Cleared May 27, 2009
RIC CONFORMAL SOURCE, MODEL 100
K090321 · ONL
Ri Consultants, LLC
Radiology · 107d
Cleared May 27, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
K090420 · OLO
Smith & Nephew, Inc.
Orthopedic · 98d
Cleared May 27, 2009
RADCALC SOFTWARE, VERSION 6.0
K090531 · MUJ
Lifeline Software, Inc.
Radiology · 89d
Cleared May 27, 2009
ORTHODONTIC CERAMIC BRACKET
K090567 · NJM
Star Dentech Korea., Corp
Dental · 85d
Cleared May 27, 2009
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE,...
K090588 · CDD
Beckman Coulter, Inc.
Chemistry · 84d
Cleared May 27, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090827 · LSL
Becton, Dickinson & CO
Microbiology · 62d
Cleared May 27, 2009
JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)
K090856 · ING
Thyssenkrupp Ceteco Srl
Physical Medicine · 58d
Cleared May 27, 2009
XYLOS POROUS SURGICAL MESH
K090880 · FTM
Xylos Corporation
General & Plastic Surgery · 57d
Cleared May 27, 2009
ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
K090943 · JJX
American Biological Technologies, Inc.
Chemistry · 54d
Cleared May 27, 2009
506CN PATIENT MONITOR
K091050 · DRT
Criticare Systems, Inc.
Cardiovascular · 44d
Cleared May 27, 2009
PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
K091097 · FYA
Promedical Products Co., Ltd.
General Hospital · 41d