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
81169–81192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2000
ML EYE SPEAR, MODEL ML 27 ES
K002279 · HOZ
Med-Logics, Inc.
Ophthalmic · 23d
Cleared Aug 18, 2000
POWERDRIVE 350 OPTION
K002415 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 10d
Cleared Aug 18, 2000
REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
K993389 · HIS
Remed Pharma
Obstetrics & Gynecology · 315d
Cleared Aug 18, 2000
REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
K993403 · HIS
Remed Pharma
Obstetrics & Gynecology · 315d
Cleared Aug 18, 2000
REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
K993409 · HIS
Remed Pharma
Obstetrics & Gynecology · 315d
Cleared Aug 17, 2000
STACKHOUSE LENS HOOD, MODEL SA-700/F
K000605 · FYA
Stackhouse, Inc.
General Hospital · 176d
Cleared Aug 17, 2000
GROSS FEMORAL COMPONENT
K001580 · MEH
Biomet, Inc.
Orthopedic · 87d
Cleared Aug 17, 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE...
K001588 · GXI
Arthrocare Corp.
Neurology · 86d
Cleared Aug 17, 2000
SYNTHES SCALLOPED DISTAL TIBIA PLATE
K001793 · LXT
Synthes (Usa)
Orthopedic · 64d
Cleared Aug 17, 2000
OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE
K001858 · KKX
China Nantong Guangda Textile Co., Ltd.
General Hospital · 59d
Cleared Aug 17, 2000
SUREFIT DISPERSIVE ELECTRODE
K002002 · GEI
Conmedcorp
General & Plastic Surgery · 48d
Cleared Aug 17, 2000
NDO SURGICAL SURGICAL OVERTUBE
K002018 · FED
Surgical, Inc.
Gastroenterology & Urology · 45d
Cleared Aug 17, 2000
PRIMAFLOW
K002086 · EBF
Dmg USA, Inc.
Dental · 38d
Cleared Aug 17, 2000
STELKAST PROVEN KNEE SYSTEM
K002281 · JWH
Stelkast Company
Orthopedic · 24d
Cleared Aug 17, 2000
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM
K002314 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 17d
Cleared Aug 17, 2000
COOLTOUCH II
K002347 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 15d
Cleared Aug 17, 2000
M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER
K002397 · IYN
Agilent Technologies, Inc.
Radiology · 10d
Cleared Aug 17, 2000
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
K993042 · MED
Medivators, Inc.
General Hospital · 342d
Cleared Aug 16, 2000
MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000
K001106 · FPA
Creative Plastic Technology
General Hospital · 133d
Cleared Aug 16, 2000
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
K001250 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 119d
Cleared Aug 16, 2000
NEURO SCAN MEDICAL SYSTEMS A4000
K001562 · IKN
Neuro Scan Labs
Neurology · 89d
Cleared Aug 16, 2000
WMT MODULAR SHOULDER SYSTEM
K001706 · KWS
Wrightmedicaltechnologyinc
Orthopedic · 72d
Cleared Aug 16, 2000
LINKMAX
K001823 · EMA
GC America, Inc.
Dental · 61d
Cleared Aug 16, 2000
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
K001969 · DQY
Medtronic Vascular
Cardiovascular · 49d