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
53185–53208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2009
THE CROSSER 14 OTW CATHETER, MODEL CRU014
K091254 · DQY
Flowcardia, Inc.
Cardiovascular · 30d
Cleared May 29, 2009
RESPIRONICS PERFORMAX TOTAL FACE MASK
K091271 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 29d
Cleared May 29, 2009
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K091329 · DYB
Terumo Medical Corp.
Cardiovascular · 24d
Cleared May 29, 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
K091435 · MQB
Canon, Inc.
Radiology · 15d
Cleared May 29, 2009
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
K091436 · MQB
Canon, Inc.
Radiology · 15d
Cleared May 28, 2009
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769 · JBQ
Siemens Healthcare Diagnostics
Hematology · 339d
Cleared May 28, 2009
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY,...
K083117 · LKO
Phadia US, Inc.
Immunology · 218d
Cleared May 28, 2009
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
K090071 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 136d
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