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
124297–124320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1990
DISPOSABLE PLASTIC VAGINAL SPECULUM
K903080 · HIB
Dawnex Industries, Inc.
Obstetrics & Gynecology · 69d
Cleared Sep 19, 1990
OTOSCREENER-I AND OTO-SCREEN-I-P
K903143 · EWO
Handtronix, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 19, 1990
TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN
K903414 · DXK
Echo Ultrasound
Cardiovascular · 51d
Cleared Sep 19, 1990
STERILE LATEX EXAMINATION GLOVES
K903447 · LYY
Sime Darby USA
General Hospital · 54d
Cleared Sep 19, 1990
ARGENCO 8 GOLD ALLOY FOR PORCELAIN
K903678 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Sep 19, 1990
THERA-CANE
K903820 · LYG
Pro Message Co.
Physical Medicine · 30d
Cleared Sep 19, 1990
VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES
K903883 · GEX
Metatech Corp.
General & Plastic Surgery · 28d
Cleared Sep 19, 1990
S.P.F. PREMIER 2 WHEELCHAIR
K904152 · IOR
Everest & Jennings, Inc.
Physical Medicine · 12d
Cleared Sep 19, 1990
PATIENT EXAMINATION GLOVES
K904190 · LYY
1st Med, Inc.
General Hospital · 7d
Cleared Sep 18, 1990
CURAPULS 403 DIATHERMY UNIT
K900189 · IMG
Henley Intl.
Physical Medicine · 245d
Cleared Sep 18, 1990
PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI.
K902876 · HQC
Intraoptics Surgical, Inc.
Ophthalmic · 78d
Cleared Sep 18, 1990
MT-336 AUTOMATIC PERIMETER
K902878 · HPT
Marco Technologies
Ophthalmic · 78d
Cleared Sep 18, 1990
RAYON NEUROLOGICAL SPONGE
K902921 · HBA
American Silk Sutures, Inc.
Neurology · 77d
Cleared Sep 18, 1990
PLAIN AND CHROMIC GUT SUTURE
K903624 · GAL
Look, Inc.
General & Plastic Surgery · 41d
Cleared Sep 18, 1990
SPA SHELL
K904106 · ILJ
Century Manufacturing Co.
Physical Medicine · 12d
Cleared Sep 17, 1990
TRI-TECH URINE SPECIMEN KIT
K900983 · FMH
Tri-Tech, Inc.
Chemistry · 199d
Cleared Sep 17, 1990
DS60 TOOTHBRUSH SANITIZER
K901459 · MCF
Associated Mills, Inc.
Dental · 173d
Cleared Sep 17, 1990
DEFIANCE MODEL FUS 336
K902685 · EAZ
Defiance Electronics, Inc.
Dental · 90d
Cleared Sep 17, 1990
MICRO-EMED-SYSTEM
K902967 · IKE
Novel Electronics, Inc.
Physical Medicine · 73d
Cleared Sep 17, 1990
MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTION
K903203 · LNH
Summit World Trade Corp.
Radiology · 59d
Cleared Sep 17, 1990
CHIROFLEX LENS MICROSERT
K903574 · KYB
Chiron Ophthalmics
Ophthalmic · 40d
Cleared Sep 17, 1990
STAGE III
K903659 · IOQ
Unique Flotation Systems, Inc.
Physical Medicine · 39d
Cleared Sep 17, 1990
STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES
K903698 · JPI
Statspin Technologies
Hematology · 33d
Cleared Sep 17, 1990
SUNGLASSES W/NON PRESCRIPT LENSES W/PHOTO SENSITIV
K903739 · HQY
Nouveau Eyewear
Ophthalmic · 32d