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
92521–92544 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1997
SIEMENS ORTHOPHOS DS/DS CEPH
K972312 · EHD
Siemens AG
Radiology · 87d
Cleared Sep 15, 1997
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
K972592 · MOS
Elscint, Inc.
Radiology · 66d
Cleared Sep 15, 1997
DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
K973044 · LZG
Disetronic Medical Systems
General Hospital · 31d
Cleared Sep 12, 1997
TELE TRENS TM 10
K960884 · DSI
Life Sensing Instrument Company, Inc.
Cardiovascular · 557d
Cleared Sep 12, 1997
BABY DOPPLEX (3000)
K963711 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 361d
Cleared Sep 12, 1997
DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
K970544 · KYJ
Depuy, Inc.
Orthopedic · 212d
Cleared Sep 12, 1997
FLOW-RITE
K971594 · EBF
Pulpdent Corp.
Dental · 134d
Cleared Sep 12, 1997
DCI WATER PURIFIER
K971727 · EIA
Dental Components, Inc.
Dental · 126d
Cleared Sep 12, 1997
BELLEGLASS HP ENAMEL REPAIR MATERIAL
K971762 · EBF
Sybron Dental Specialties, Inc.
Dental · 122d
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