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
92017–92040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1997
PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE
K972009 · KGO
Tillotson Healthcare Corp.
General Hospital · 105d
Cleared Sep 12, 1997
NELLCOR PURITAN BENNETT GEMINI
K972248 · CBK
Nellcor Puritan Bennett, Inc.
Anesthesiology · 88d
Cleared Sep 12, 1997
ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
K972249 · EHD
Pelton & Crane Co.
Radiology · 88d
Cleared Sep 12, 1997
FIRST MIDCATH CATHETER
K972254 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 88d
Cleared Sep 12, 1997
FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS)
K972256 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 88d
Cleared Sep 12, 1997
MIDAS REX MOTOR
K972289 · HBB
Midas Rex Pneumatic Tools, Inc.
Neurology · 85d
Cleared Sep 12, 1997
POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION...
K972306 · LZA
P.T. Irama Dinamika Latex
General Hospital · 85d
Cleared Sep 12, 1997
AURADAPT AUBTMENT SYSTEM
K972475 · NHA
Nobel Biocare Uas, Inc.
Dental · 73d
Cleared Sep 12, 1997
WAKO NEFA LINEARITY SET
K973072 · JJX
Wako Chemicals USA, Inc.
Toxicology · 25d
Cleared Sep 12, 1997
LIDOCAINE EIA ASSAY
K973102 · KLR
Diagnostic Reagents, Inc.
Toxicology · 24d
Cleared Sep 12, 1997
BIG BAG 3000 PRESSURE INFUSOR
K973133 · FRN
Byron Medical
General Hospital · 22d
Cleared Sep 12, 1997
MODIFICATION OF OPUS FERRITIN TEST SYSTEM
K973202 · DBF
Behring Diagnostics, Inc.
Immunology · 66d
Cleared Sep 12, 1997
DENTIN CONDITIONING AND ADHESIVE (BOND 1)
K973388 · KLE
Jeneric/Pentron, Inc.
Dental · 3d
Cleared Sep 11, 1997
INFIMED DENTAL SYSTEM
K962422 · EHD
Infimed, Inc.
Radiology · 444d
Cleared Sep 11, 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K964624 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 303d
Cleared Sep 11, 1997
MICROJET CAVITY PREPARATION SYSTEM
K964755 · KOJ
Midwest Dental Products Corp.
Dental · 288d
Cleared Sep 11, 1997
HP ORVUE INTRA-OP (M2510A)
K965160 · BSZ
Hewlett-Packard GmbH
Anesthesiology · 262d
Cleared Sep 11, 1997
MICROMARK CLIP
K970817 · GDW
Biopsys Medical, Inc.
General & Plastic Surgery · 189d
Cleared Sep 11, 1997
FINESSE ALL-CERAMIC SYSTEM
K971869 · EIH
Dentsply Intl.
Dental · 113d
Cleared Sep 11, 1997
GETTIG STYRL-JECT DELIVERY SYSTEM
K972285 · EJI
Gettig Pharmaceutical Instrument Co.
Dental · 84d
Cleared Sep 11, 1997
BIOZ SYSTEM & BIOZ PORTABLE
K972320 · DSB
Cardiodynamics International Corp.
Cardiovascular · 80d
Cleared Sep 11, 1997
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
K972380 · LMB
Eastman Kodak Company
Radiology · 77d
Cleared Sep 11, 1997
ROOT APEX LOCATOR
K972407 · LQY
Toei Electric Co., Ltd.
Dental · 77d
Cleared Sep 11, 1997
ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM
K972435 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 73d