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
126505–126528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1990
BOWEN ELECTRODE SKIN PREPATORY CLEANSER
K896898 · LKB
Bowen & Company, Inc.
General Hospital · 117d
Cleared Apr 04, 1990
INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.
K897093 · HNF
Microline Pentax, Inc.
Ophthalmic · 105d
Cleared Apr 04, 1990
MITEK ANCHOR(TM)
K897155 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 99d
Cleared Apr 04, 1990
MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR
K900091 · HQG
Onufryk Low Vision Ent.
Ophthalmic · 89d
Cleared Apr 04, 1990
AUTO SUTURE SURGIPORT SPIRAL SLEEVE
K900123 · FBQ
United States Surgical, A Division of...
General & Plastic Surgery · 85d
Cleared Apr 04, 1990
SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY
K900346 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 71d
Cleared Apr 04, 1990
SALIVA ABSORBER - DENTAL
K900631 · DYN
Kab Gloves Unltd.
Dental · 55d
Cleared Apr 04, 1990
HEARING AID (ALL-IN-THE-EAR)
K900789 · ESD
Solar Aid Corp.
Ear, Nose, Throat · 43d
Cleared Apr 04, 1990
CARDISUNY, 501BX
K900849 · LOS
Graham-Field, Inc.
Cardiovascular · 41d
Cleared Apr 04, 1990
DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT
K900861 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 04, 1990
OXIMAX 700
K900866 · DQA
Pace Tech, Inc.
Anesthesiology · 40d
Cleared Apr 04, 1990
ALTERNATING PRESSURE PUMP AND PAD SYSTEM
K900871 · FNM
Three Bears Intl.
General Hospital · 39d
Cleared Apr 04, 1990
ADLER DISPOSABLE BIPOLAR CORD
K900913 · HQO
Adler Instrument Co.
Ophthalmic · 36d
Cleared Apr 04, 1990
DIACAM GAMMA CAMERA SYSTEM
K901019 · KPS
Siemens Gammasonics, Inc.
Radiology · 29d
Cleared Apr 04, 1990
PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA
K901032 · DPS
Accucore, Inc.
Cardiovascular · 29d
Cleared Apr 04, 1990
REDYPLATE DISPOSABLE LEG PLATE
K901152 · HGP
Medical Accessories, Inc.
Obstetrics & Gynecology · 22d
Cleared Apr 03, 1990
MXR-14 FILM PROCESSOR
K890486 · IXW
Cordell, Inc.
Radiology · 427d
Cleared Apr 03, 1990
STEADFAST DENTURE ADHESIVE CREAM
K895818 · KOT
Stiefel Research Institute, Inc.
Dental · 186d
Cleared Apr 03, 1990
LDW SPIROMETRY SYSTEM
K896300 · BZG
Lanpher Diagnostic Workstations, Inc.
Anesthesiology · 155d
Cleared Apr 03, 1990
EXEC-WASH SOLID PHASE WASHING SYSTEM
K896631 · JQW
Source Scientific Systems, Inc.
Chemistry · 132d
Cleared Apr 03, 1990
SIGMA PROCEDURE NO. 735
K897147 · KHP
Sigma Diagnostics, Inc.
Chemistry · 98d
Cleared Apr 03, 1990
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
K900010 · JFT
Kallestad Diag, A Div. of Erbamont, Inc.
Toxicology · 91d
Cleared Apr 03, 1990
ARISTEE (RESIN, CROWN AND BRIDGES)
K900068 · EBG
Prometex, Inc.
Dental · 89d
Cleared Apr 03, 1990
FG DIAMOND BURRS
K900089 · DZP
Kab Gloves Unltd.
Dental · 88d