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
87817–87840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 21, 1998
ISOLA SPINAL SYSTEM
K980485 · MNI
Acromed Corp.
Orthopedic · 254d
Cleared Oct 21, 1998
VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH...
K980601 · JAQ
Varian Assoc., Inc.
Radiology · 246d
Cleared Oct 21, 1998
SLE EMG ELECTRODES AND ACCESSORIES
K981004 · IKT
Specialized Laboratory Equipment, Ltd.
Neurology · 217d
Cleared Oct 21, 1998
TFR
K981208 · JNM
Ramco Laboratories, Inc.
Immunology · 202d
Cleared Oct 21, 1998
MGB LAPALUX TELESCOPE
K982013 · GCJ
Mgb Endoskopische Gerate GmbH
General & Plastic Surgery · 135d
Cleared Oct 21, 1998
AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
K982566 · EWO
Bar - Advanced Control Systems , Ltd.
Ear, Nose, Throat · 90d
Cleared Oct 21, 1998
NEUFINISH RESURFACING CREAM
K982577 · MGQ
Neutrogena Corp.
General & Plastic Surgery · 89d
Cleared Oct 21, 1998
DOCKING-EXTENSION WIRE
K982592 · DQX
Schneider (Europe) GmbH
Cardiovascular · 89d
Cleared Oct 21, 1998
ECHO-SCREEN
K982642 · EWO
Fischer-Zoth Audiologic Systems, Inc.
Ear, Nose, Throat · 84d