FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80209–80232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2000
THERMAGE THERMACOOL II SYSTEM
K003183 · GEI
Thermage, Inc.
General & Plastic Surgery · 58d
Cleared Dec 08, 2000
OPUS ROD FIXATION SYSTEM
K003490 · MNH
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Dec 08, 2000
NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP,...
K003674 · GEI
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 9d
Cleared Dec 08, 2000
SW ULTRASOUND, MODELS 331, 311, 333
K991613 · IMI
Starbene
Physical Medicine · 578d
Cleared Dec 07, 2000
TCM400
K001866 · LPP
Radiometer Medical A/S
Anesthesiology · 170d
Cleared Dec 07, 2000
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
K002481 · LDF
Zcv ,Inc.
Cardiovascular · 115d
Cleared Dec 07, 2000
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
K003448 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 31d
Cleared Dec 07, 2000
INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
K003450 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 07, 2000
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
K003452 · DRF
Ep Technologies, Inc.
Cardiovascular · 30d
Cleared Dec 06, 2000
DARDIK CAROTID SHUNT
K001621 · MJN
Vascutech, Inc.
Cardiovascular · 194d
Cleared Dec 06, 2000
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
K001976 · DIS
OraSure Technologies, Inc.
Toxicology · 160d
Cleared Dec 06, 2000
SLEEPSTRIP DISPOSABLE APNEA SCREENER
K002135 · MNR
Influent , Ltd.
Anesthesiology · 145d
Cleared Dec 06, 2000
AEDEFIBRILLATOR
K002232 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 135d
Cleared Dec 06, 2000
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
K002794 · CBF
Hypertec, Inc.
Anesthesiology · 90d
Cleared Dec 06, 2000
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
K002795 · CBF
Hypertec, Inc.
Anesthesiology · 90d
Cleared Dec 06, 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798 · JEY
Codman & Shurtleff, Inc.
Dental · 90d
Cleared Dec 06, 2000
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
K003455 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 29d
Cleared Dec 06, 2000
EECP THERAPY SYSTEM, MODEL TS3
K003469 · DRN
Vasomedical, Inc.
Cardiovascular · 28d
Cleared Dec 06, 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
K003483 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 27d
Cleared Dec 05, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
K000582 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 287d
Cleared Dec 05, 2000
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND...
K001465 · FIB
Nipro Medical Corp.
Gastroenterology & Urology · 209d
Cleared Dec 05, 2000
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105 · MLD
Siemens Medical Solutions USA, Inc.
Cardiovascular · 146d
Cleared Dec 05, 2000
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
K002128 · NDR
Diagnostic Systems Laboratories, Inc.
Chemistry · 144d
Cleared Dec 05, 2000
ACAPELLA
K002768 · BWF
Dhd Healthcare Corp.
Anesthesiology · 90d