FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81673–81696 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2000
ORTHONE
K001773 · LNH
Oni, Inc.
Radiology · 67d
Cleared Aug 18, 2000
PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325
K001827 · FPA
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
PARADIGM 1.5ML RESERVOIR, MODEL 326
K001828 · FRN
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
MINIMED PARADIGM INSULIN PUMP, MODEL 511
K001829 · FRN
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318
K001832 · FPA
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
KONTUR 55 SOFT LENS
K001908 · LPL
Kontur Kontact Lens Co., Inc.
Ophthalmic · 57d
Cleared Aug 18, 2000
TREATVISION
K002194 · LHN
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Aug 18, 2000
GE MARQUETTE ECG ANALYSIS PROGRAM
K002209 · MHX
General Electric Medical Systems...
Cardiovascular · 28d
Cleared Aug 18, 2000
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · DRX
Cambridge Heart, Inc.
Cardiovascular · 25d
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