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
83041–83064 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2000
RTLX
K992392 · MUH
Infimed, Inc.
Radiology · 256d
Cleared Mar 31, 2000
BITX PROBES
K993412 · GEI
Everest Medical Corp.
General & Plastic Surgery · 171d
Cleared Mar 31, 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K993512 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 165d
Cleared Mar 31, 2000
ISOSEED PD-103
K993552 · KXK
Bebig Isotopentechnik GmbH
Radiology · 163d
Cleared Mar 30, 2000
BRANEMARK NOVUM
K000018 · DZE
Nobel Biocare Uas, Inc.
Dental · 86d
Cleared Mar 30, 2000
LEVEEN NEEDLE ELECTRODE
K000032 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 85d
Cleared Mar 30, 2000
MONOFILAMENT BIOSYN SUTURE
K000037 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 84d
Cleared Mar 30, 2000
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
K000046 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 83d
Cleared Mar 30, 2000
VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5
K000369 · FMI
Medpro Technologies, Inc.
General Hospital · 55d
Cleared Mar 30, 2000
DIMENSION GARANT L, DIMENSION GARANT L QUICK
K000588 · ELW
Espe Dental AG
Dental · 37d
Cleared Mar 30, 2000
DIMENSION PENTA H, DIMENSION PENTA H QUICK
K000591 · ELW
Espe Dental AG
Dental · 37d
Cleared Mar 30, 2000
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
K000697 · BZE
Allegiance Healthcare Corp.
Anesthesiology · 29d
Cleared Mar 30, 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
K000717 · OCW
Smith & Nephew, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 30, 2000
COLORADO II SPINAL SYSTEM
K984360 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 479d
Cleared Mar 30, 2000
PACIFIC SURGICAL PATTIES
K993019 · HBA
V. Mueller Neuro/Spine
Neurology · 204d
Cleared Mar 30, 2000
OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND...
K993041 · FAJ
The Olympus Optical Co.
Gastroenterology & Urology · 202d
Cleared Mar 30, 2000
MICRINS MICROSURGICAL SUTURE
K993970 · GAR
Micrins Surgical, Inc.
General & Plastic Surgery · 128d
Cleared Mar 29, 2000
SINGLE SIZE TENDON SPACER
K000019 · HXA
Medist International
Orthopedic · 85d
Cleared Mar 29, 2000
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
K000154 · FWN
E. Benson Hood Lab, Inc.
Ear, Nose, Throat · 70d
Cleared Mar 29, 2000
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
K000292 · LLZ
Barco N.V.
Radiology · 58d
Cleared Mar 29, 2000
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
K000293 · LLZ
Barco N.V.
Radiology · 58d
Cleared Mar 29, 2000
HARDYDISK, TETRACYCLINE 30MCG
K000304 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Mar 29, 2000
SPIRO PRO
K000648 · BTY
Erich Jaeger GmbH
Anesthesiology · 30d
Cleared Mar 29, 2000
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
K000659 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 30d