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
77689–77712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2001
MODIFICATION TO N/T PROTEIN CONTROL SL
K012468 · JJY
Dade Behring, Inc.
Chemistry · 33d
Cleared Sep 04, 2001
MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET...
K012541 · LDJ
Branan Medical Corp.
Toxicology · 28d
Cleared Sep 04, 2001
ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL
K012799 · GEI
Senorx, Inc.
General & Plastic Surgery · 14d
Cleared Aug 31, 2001
STRYKER NAVIGATION SYSTEM-KNEE MODULE
K010204 · HAW
Stryker Corp.
Neurology · 220d
Cleared Aug 31, 2001
MBI PD-103 SL
K011427 · KXK
Mills Biopharmaceuticals, Inc.
Radiology · 115d
Cleared Aug 31, 2001
TENS CARE, MODEL XL-Y3
K011543 · GZJ
Tenscare, Ltd.
Neurology · 105d
Cleared Aug 31, 2001
OLYMPUS SUCTION PUMP, MODEL KV-5
K011725 · JCX
Keymed (Medical & Industrial...
General & Plastic Surgery · 88d
Cleared Aug 31, 2001
INTERCEPT-URETHRAL MICROCOIL
K011781 · MOS
Surgi-Vision, Inc.
Radiology · 85d
Cleared Aug 31, 2001
DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
K011873 · LNS
Dornier
Gastroenterology & Urology · 77d
Cleared Aug 31, 2001
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011912 · MBI
Axya Medical, Inc.
Orthopedic · 73d
Cleared Aug 31, 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162 · HRS
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
K012292 · CFN
The Binding Site, Ltd.
Immunology · 42d
Cleared Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
K012296 · CFN
The Binding Site, Ltd.
Immunology · 42d
Cleared Aug 31, 2001
COALESCENT SURGICAL U-CLIP
K012317 · FZP
Coalescent Surgical
General & Plastic Surgery · 39d
Cleared Aug 31, 2001
MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
K012476 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 31, 2001
AA-1 SYSTEM
K012530 · HJT
Neurovision, Inc.
Ophthalmic · 25d
Cleared Aug 31, 2001
EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
K012663 · IZL
Sedecal USA, Inc.
Radiology · 18d
Cleared Aug 30, 2001
JET THERAPY
K002908 · ISA
Jet Therapy
Physical Medicine · 346d
Cleared Aug 30, 2001
SENSI-PREMA NEONATAL ECG ELECTRODES,...
K003804 · DRX
Niko Medical Products
Cardiovascular · 265d
Cleared Aug 30, 2001
EXEL I.V. ADMINISTRATION SET
K010404 · FPA
Exelint Intl. Co.
General Hospital · 199d
Cleared Aug 30, 2001
VECTORVISION CT/FLUORO
K010968 · HAW
Brainlab AG
Neurology · 150d
Cleared Aug 30, 2001
THE UNI-CLIP STAPLE
K011716 · JDR
New Deal, S.A.
Orthopedic · 87d
Cleared Aug 30, 2001
ATRICURE BIPOLAR COAGULATION SYSTEM
K011722 · GEI
AtriCure, Inc.
General & Plastic Surgery · 87d
Cleared Aug 30, 2001
SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
K011729 · DTC
Dni Nevada, Inc.
Cardiovascular · 87d