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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
149569–149592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1985
ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED
K850150 · FMK
Gainor Medical
General & Plastic Surgery · 38d
Cleared Feb 21, 1985
MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN)
K850177 · FYA
Matrix Medica, Inc.
General Hospital · 35d
Cleared Feb 21, 1985
MEDICAL MULTI-IMAGE CAMERA-676
K850184 · LMC
Dunn Instruments, Inc.
Radiology · 34d
Cleared Feb 21, 1985
POLY-LINED TOWEL/DRAPE LINE
K850199 · KKX
Excel Health Care Products
General Hospital · 34d
Cleared Feb 21, 1985
PHILIPS UV-A SOLARIUM TYPE HP 3016-SUNLAMP
K850203 · FTC
Philips Int'L B.V.
General & Plastic Surgery · 34d
Cleared Feb 21, 1985
PHILIPS UV-A SOLARIUM TYPE HP 3130-SUNLAMP
K850204 · FTC
Philips Int'L B.V.
General & Plastic Surgery · 34d
Cleared Feb 21, 1985
PHILIPS UV-A SOLARIUM TYPE HP 3127-SUNLAMP
K850205 · FTC
Philips Int'L B.V.
General & Plastic Surgery · 34d
Cleared Feb 21, 1985
PHILIPS UV-A SOLARIUM TYPE HP 3126-SUNLAMP
K850206 · FTC
Philips Int'L B.V.
General & Plastic Surgery · 34d
Cleared Feb 21, 1985
AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM
K850406 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 17d
Cleared Feb 20, 1985
ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO
K844220 · DSP
Aries Medical, Inc.
Cardiovascular · 112d
Cleared Feb 20, 1985
HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE
K844371 · GEI
Consolidated Medical Equipment, Inc.
General & Plastic Surgery · 99d
Cleared Feb 20, 1985
MODEL FORCE 2 ELECTROSURGICAL GENERATOR
K844403 · GEI
Valleylab, Inc.
General & Plastic Surgery · 99d
Cleared Feb 20, 1985
RADIOTOM 804
K844428 · GEI
Siemens Medical Solutions USA, Inc.
Radiology · 96d
Cleared Feb 20, 1985
PERIFLUX PF-2
K844631 · DPW
Medex, Inc.
Cardiovascular · 85d
Cleared Feb 20, 1985
ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON
K844856 · DRX
Bristol Medical Electronics Corp.
Cardiovascular · 68d
Cleared Feb 19, 1985
CARBON DIOXIDE LASER ML 825
K833528 · HHR
Merrimack Laboratories
Obstetrics & Gynecology · 515d
Cleared Feb 19, 1985
EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS
K842133 · FOZ
Cardio Search, Inc.
General Hospital · 265d
Cleared Feb 19, 1985
MODIFICATION OF ABL MIC-10 PRECEPT SYS
K843612 · LTD
Austin Biological Laboratories
Microbiology · 159d
Cleared Feb 19, 1985
LINEAR LIFT DEVICE
K844368 · IKK
Cybex
Physical Medicine · 98d
Cleared Feb 19, 1985
MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT
K844482 · JDL
Advanced Biosearch Assn.
Orthopedic · 92d
Cleared Feb 19, 1985
MECRON MRC-HEADLESS FEMORAL COMPONENT
K844486 · KWL
Mecron Medical Products, Inc.
Orthopedic · 92d
Cleared Feb 19, 1985
MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR
K844487 · KWL
Mecron Medical Products, Inc.
Orthopedic · 92d
Cleared Feb 19, 1985
HYDROSET ROOT CANAL SEALER
K844635 · KIF
Lund Manufacturing Co.
Dental · 83d
Cleared Feb 19, 1985
TRICON REVISION TOTAL KNEE SYSTEM
K844706 · HSX
Richards Medical Co., Inc.
Orthopedic · 78d