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
75937–75960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2002
STEALTHSTATION WITH FLUOROMERGE SOFTWARE
K020338 · HAW
Medtronic Surgical Navigation...
Neurology · 26d
Cleared Feb 27, 2002
DEPILASE YAG LASE PLUS LASER SYSTEM
K020463 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 15d
Cleared Feb 26, 2002
RUSCH MILLER-ABBOTT TUBE
K010797 · KNT
Rusch Intl.
Gastroenterology & Urology · 347d
Cleared Feb 26, 2002
RUSCH CANTOR TUBE
K010798 · KNT
Rusch Intl.
Gastroenterology & Urology · 347d
Cleared Feb 26, 2002
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K013107 · HWC
Karl Storz Endoscopy
Orthopedic · 162d
Cleared Feb 26, 2002
WIN-2 TANGO ELITE NP
K013361 · ITI
Durable Medical Equipment, Inc.
Physical Medicine · 139d
Cleared Feb 26, 2002
LASER SYSTEM YELLOWSTAR
K013940 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 89d
Cleared Feb 26, 2002
AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE...
K013953 · LYY
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 88d
Cleared Feb 26, 2002
ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
K013973 · LPL
Vistakon
Ophthalmic · 85d
Cleared Feb 26, 2002
LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL,...
K013996 · LYY
Pt. Maja Agung Latexindo
General Hospital · 85d
Cleared Feb 26, 2002
VINYL EXAMINATION GLOVES STERILE POWEDERED
K020044 · LYZ
Primus Gloves Private , Ltd.
General Hospital · 50d
Cleared Feb 26, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020132 · DXZ
Chase Medical, Inc.
Cardiovascular · 42d
Cleared Feb 26, 2002
MEDIAL ROTATION KNEE SYSTEM
K020214 · JWH
Engineering Consulting Services, Inc.
Orthopedic · 35d
Cleared Feb 26, 2002
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
K020351 · DTZ
Dideco S.P.A.
Cardiovascular · 22d
Cleared Feb 26, 2002
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
K020352 · HWC
Unitedstates Surgical
Orthopedic · 22d
Cleared Feb 26, 2002
MSD WIRE SYSTEM
K020426 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
Cleared Feb 26, 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE
K020493 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 13d
Cleared Feb 25, 2002
WAVELENGHT ULTRASOUND LOTION
K013212 · MUI
National Therapy Products, Inc.
Radiology · 153d
Cleared Feb 25, 2002
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER
K013923 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared Feb 25, 2002
AARON REUSABLE ELECTROSURGICAL ELECTRODE
K014201 · GEI
Aaron Medical Industries
General & Plastic Surgery · 66d
Cleared Feb 22, 2002
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
K011404 · BSZ
Draeger Medical, Inc.
Anesthesiology · 290d
Cleared Feb 22, 2002
SPIRABRUSH CX BIOPSY INSTRUMENT
K011488 · HFB
Trylon Corp.
Obstetrics & Gynecology · 283d
Cleared Feb 22, 2002
BIOSORBFX O/M 2.0/2/4 SYSTEM
K011569 · JEY
Bionx Implants, Inc.
Dental · 277d
Cleared Feb 22, 2002
BREATHING CIRCUIT FILTER
K012958 · CAH
Emergency Filtration Products, Inc.
General Hospital · 171d