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
115321–115344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1992
CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES
K924271 · FCG
Core Medical, Inc.
Gastroenterology & Urology · 91d
Cleared Nov 23, 1992
DEBRACKETING INSTRUMENT
K924295 · JEX
Unitek Corp.
Dental · 89d
Cleared Nov 23, 1992
AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
K924348 · HAW
Ad-Tech Medical Instrument Corp
Neurology · 88d
Cleared Nov 23, 1992
RESTRAINT, PROTECTIVE N0. 103
K924566 · KMK
Ansley Medical Products, Inc.
General Hospital · 75d
Cleared Nov 23, 1992
FOLEY CATHETER TUBE HOLDER NO. 101
K924567 · KMK
Ansley Medical Products, Inc.
General Hospital · 75d
Cleared Nov 23, 1992
TUBE, LEAD, AND CORD HOLDER NO. 102
K924568 · KMK
Ansley Medical Products, Inc.
General Hospital · 75d
Cleared Nov 23, 1992
DENTIN RELIEF
K924670 · KLE
Professional Technologies Corp.
Dental · 68d
Cleared Nov 23, 1992
TRELEX MESH
K924749 · FTL
Meadox Medicals, Div. Boston...
General & Plastic Surgery · 62d
Cleared Nov 20, 1992
OFF-LINE ANALYSIS SYSTEM
K921216 · DQK
Softheart, Inc.
Cardiovascular · 252d
Cleared Nov 20, 1992
FX-CABLELOK SYSTEM
K922142 · JDQ
Bio-Tech Co.
Orthopedic · 198d
Cleared Nov 20, 1992
COMPACT SPACER
K922187 · CAF
Glaxo, Inc.
Anesthesiology · 193d
Cleared Nov 20, 1992
IPI IMPORT
K922419 · LJT
Pudenz-Schulte Medical Research Corp.
General Hospital · 183d
Cleared Nov 20, 1992
ORIGIN FLEXIBLE PORT
K922751 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 165d
Cleared Nov 20, 1992
INCISOR I PULSED ND:YAG LASER SYSTEM
K922901 · GEX
Buckman Co., Inc.
General & Plastic Surgery · 157d
Cleared Nov 20, 1992
O.R. CONCEPTS ELECTROSURGICAL PROBES
K923199 · GEI
O.R. Concepts, Inc.
General & Plastic Surgery · 143d
Cleared Nov 20, 1992
O.R. CONCEPTS' ELECTROSURGICAL PROBE
K923416 · GEI
O.R. Concepts, Inc.
General & Plastic Surgery · 133d
Cleared Nov 20, 1992
POLY DIAGNOST CDX
K923654 · IZI
Xre Corp.
Radiology · 122d
Cleared Nov 20, 1992
HANDISOL
K924077 · FTC
National Biological Corp.
General & Plastic Surgery · 100d
Cleared Nov 20, 1992
NAMTAI ELECTRONIC BLOOD PRESSURE METER
K924210 · DXN
Nam Tai Electronics (Canada) , Ltd.
Cardiovascular · 92d
Cleared Nov 19, 1992
LACERATION REPAIR TRAY
K921988 · MDM
Cypress Medical Products, Ltd.
General & Plastic Surgery · 205d
Cleared Nov 19, 1992
OLYMPUS INORGANIC PHOSPHORUS REAGENT
K925057 · CEO
Olympus Corp.
Chemistry · 44d
Cleared Nov 18, 1992
BRANDT ESOPHAGEAL CYTOLOGY BALLOON
K911588 · EOX
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 589d
Cleared Nov 18, 1992
CUTTING AND COAGULATION DEVICES AND ACCESSORIES
K921696 · GEI
American Cyanamid Co.
General & Plastic Surgery · 224d
Cleared Nov 18, 1992
INTELIJET SUCTION SUPPLY
K922176 · BTA
Smith & Nephew Dyonics, Inc.
General & Plastic Surgery · 194d