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
88321–88344 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
K982725 · ITX
Olympus America, Inc.
Radiology · 79d
Cleared Oct 23, 1998
BIO PONTOSTAR
K983077 · EJT
Bego U.S.A.
Dental · 51d
Cleared Oct 23, 1998
BEGOPAL
K983078 · EJS
Bego U.S.A.
Dental · 51d
Cleared Oct 23, 1998
PLATINLLOYD 100
K983079 · EJT
Bego U.S.A.
Dental · 51d
Cleared Oct 22, 1998
ATLANT'S
K974395 · IRP
Grad-Line Corp.
Physical Medicine · 335d
Cleared Oct 22, 1998
SLE ELECTRODES AND ACCESSORIES
K980410 · GXY
Specialized Laboratory Equipment, Ltd.
Neurology · 261d
Cleared Oct 22, 1998
VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH...
K980590 · JAQ
Varian Medical Systems, Inc.
Radiology · 247d
Cleared Oct 22, 1998
EXMOOR MYRINGOTOMY KIT
K980828 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 233d
Cleared Oct 22, 1998
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
K981209 · MVM
The Binding Site, Ltd.
Immunology · 203d
Cleared Oct 22, 1998
WILLI GELLER CREATION PORCELAIN
K981490 · EIH
Jensen Industries, Inc.
Dental · 178d
Cleared Oct 22, 1998
OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT
K982133 · HRX
The Olympus Optical Co.
Orthopedic · 127d
Cleared Oct 22, 1998
MODEL 2000 PULSE OXIMETER
K982255 · DQA
Ivy Biomedical Systems, Inc.
Anesthesiology · 118d
Cleared Oct 22, 1998
UNICAP GLIADIN IGA ASSAY
K982533 · MST
Pharmacia & Upjohn Co.
Immunology · 94d
Cleared Oct 22, 1998
FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476
K982576 · DZE
Friatec AG
Dental · 90d
Cleared Oct 22, 1998
BIRD MONITOR INTERFACE
K982580 · CBK
Bird Products Corp.
Anesthesiology · 90d
Cleared Oct 22, 1998
LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430...
K982593 · EFB
Dentalez Group
Dental · 90d
Cleared Oct 22, 1998
STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC
K982692 · EBF
Sterngold/Implamed
Dental · 80d
Cleared Oct 22, 1998
UNICAP GLIADIN IGG ASSAY
K982701 · MST
Pharmacia & Upjohn Co.
Immunology · 94d
Cleared Oct 22, 1998
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
K982714 · DBF
Bayer Corp.
Immunology · 79d
Cleared Oct 22, 1998
JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027,...
K982761 · LNH
Chamco, Inc.
Radiology · 77d
Cleared Oct 22, 1998
ZINC PHOSPHATE CEMENT
K983018 · EMA
Medental Intl.
Dental · 55d
Cleared Oct 22, 1998
ORTHOPHOS 5/PLUS/CD
K983057 · MUH
Sirona Dental Systems GmbH
Radiology · 51d
Cleared Oct 22, 1998
VFE
K983107 · GGP
Ramco Laboratories, Inc.
Hematology · 48d
Cleared Oct 21, 1998
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013
K974891 · MGP
Acutek Adhesive Specialties, Inc.
General & Plastic Surgery · 295d