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
83233–83256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2000
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
K994216 · LJT
Sims Deltec, Inc.
General Hospital · 43d
Cleared Jan 24, 2000
BABY DOPPLEX 4000, MODEL BD 4000
K990569 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 335d
Cleared Jan 24, 2000
PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
K992786 · FIP
Pure Water, Inc.
Gastroenterology & Urology · 158d
Cleared Jan 24, 2000
PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL...
K993058 · FIN
Pure Water, Inc.
Gastroenterology & Urology · 133d
Cleared Jan 24, 2000
MD 420/440/460/470/480/490
K993200 · FIP
Isopure, Corp.
Gastroenterology & Urology · 122d
Cleared Jan 24, 2000
POWERHEART AECD
K993533 · MKJ
Cardiac Science, Inc.
Cardiovascular · 97d
Cleared Jan 24, 2000
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
K993622 · GZL
Alpha Omega , Ltd.
Neurology · 90d
Cleared Jan 24, 2000
CANDELA SCLERO LONG PULSE DYE LASER
K993671 · GEX
Candela Corp.
General & Plastic Surgery · 84d
Cleared Jan 24, 2000
RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS)...
K993961 · LDJ
American Bio Medica Corp.
Toxicology · 63d
Cleared Jan 24, 2000
SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
K994263 · HFW
Precision Dynamics Corp.
Obstetrics & Gynecology · 38d
Cleared Jan 24, 2000
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K994418 · HIH
Ethicon, Inc.
Obstetrics & Gynecology · 26d
Cleared Jan 21, 2000
DERMAFREEZE
K992286 · MLY
Rhealm Pharmaceuticals, Inc.
Physical Medicine · 198d
Cleared Jan 21, 2000
MRP-TITAN
K992403 · LZO
Rotec Medizintechnik GmbH
Orthopedic · 186d
Cleared Jan 21, 2000
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
K992855 · QPB
Xomed, Inc.
General & Plastic Surgery · 150d
Cleared Jan 21, 2000
GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH...
K993415 · HCG
Boston Scientific, Target
Neurology · 112d
Cleared Jan 21, 2000
GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI...
K993417 · HCG
Boston Scientific, Target
Neurology · 112d
Cleared Jan 21, 2000
FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
K993418 · HCG
Boston Scientific, Target
Neurology · 112d
Cleared Jan 21, 2000
ABI VEST AIRWAY CLEARANCE SYSTEM
K993629 · BYI
American Biosystems, Inc.
Anesthesiology · 86d
Cleared Jan 21, 2000
CITATION TMZF HA STEM
K993768 · MEH
Howmedica Osteonics Corp.
Orthopedic · 74d
Cleared Jan 21, 2000
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER...
K994331 · MXC
Medtronic Vascular
Cardiovascular · 29d
Cleared Jan 20, 2000
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
K000067 · CJE
Teco Diagnostics
Chemistry · 10d
Cleared Jan 20, 2000
GOWN BACK, MODEL 13-403N
K992436 · FYA
Techstyles
General Hospital · 182d
Cleared Jan 20, 2000
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
K992634 · LAF
Diagnostic Products Corp.
Toxicology · 167d
Cleared Jan 20, 2000
PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
K992675 · LZA
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 163d