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
92329–92352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1997
POWDER FREE LATEX EXAMINATION GLOVES
K970115 · LYY
Pt Mbf Buana Multicorpora
General Hospital · 214d
Cleared Aug 15, 1997
PRINTER INTERFACE
K970305 · DXH
Micromedical, Inc.
Cardiovascular · 200d
Cleared Aug 15, 1997
SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER
K970348 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 198d
Cleared Aug 15, 1997
E-READER
K970436 · GZO
Natural Herbal Products, Inc.
Neurology · 191d
Cleared Aug 15, 1997
ENTERAL NUTRITION 1000 ML/500ML
K970849 · KNT
Medical Infusion Technologies, Inc.
Gastroenterology & Urology · 161d
Cleared Aug 15, 1997
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839 · KPQ
Varian Medical Systems, Inc.
Radiology · 88d
Cleared Aug 15, 1997
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
K971845 · ESD
Sound Hearing Instruments, Inc.
Ear, Nose, Throat · 88d
Cleared Aug 15, 1997
TDK MEDICAL GRADE CD-R
K971848 · LMB
Tdk Electronics Corporation of America
Radiology · 88d
Cleared Aug 15, 1997
AIR CONDUCTION HAEARING AIDS
K971852 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 87d
Cleared Aug 15, 1997
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
K971937 · OCY
Terumo Medical Corp.
Gastroenterology & Urology · 80d
Cleared Aug 15, 1997
PASCO MIC AND MIC/ID PANELS
K971951 · JWY
Pasco Laboratories, Inc.
Microbiology · 79d
Cleared Aug 15, 1997
OXLIFE EXCELL OXYGEN CONCENTRATORS
K971964 · CAW
Oxlife, Inc.
Anesthesiology · 79d
Cleared Aug 15, 1997
FULL BODY RESTRAINT SYSTEM
K972046 · FMQ
Gillen Industries
General Hospital · 74d
Cleared Aug 15, 1997
LORIPRO, LORIPRO II
K972058 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 74d
Cleared Aug 15, 1997
LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES
K972104 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 72d
Cleared Aug 15, 1997
PHONAK NOVO FORTE E3
K972106 · ESD
Phonak, Inc.
Ear, Nose, Throat · 71d
Cleared Aug 15, 1997
MINIMED INFUSION PUMP, MODEL 507C
K972107 · LZG
Medtronic Minimed
General Hospital · 71d
Cleared Aug 15, 1997
VERA PDN
K972118 · EJH
Aalba Dent, Inc.
Dental · 71d
Cleared Aug 15, 1997
DEVMED STEPPING AND STABILIZING SYSTEM
K972152 · ITX
Devmed Corp.
Radiology · 67d
Cleared Aug 15, 1997
MEDI-SIS SYRINGE INFUSION SYSTEM
K972173 · MEB
I-Flow Corp.
General Hospital · 67d
Cleared Aug 15, 1997
CEREC 2 CROWN SOFTWARE
K972276 · ELW
Siemens AG
Dental · 58d
Cleared Aug 15, 1997
IL TEST IRON
K972363 · JIY
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Aug 15, 1997
SEALAPEX
K972369 · KIF
Sybron Dental Specialties, Inc.
Dental · 51d
Cleared Aug 15, 1997
ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM
K972465 · IYN
Aloka Co., Ltd.
Radiology · 45d