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
83065–83088 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2000
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN...
K000671 · LYY
Sgmp Co., Ltd.
General Hospital · 30d
Cleared Mar 29, 2000
ZUMA GUIDE CATHETERS
K000677 · DQY
Medtronic Vascular
Cardiovascular · 29d
Cleared Mar 29, 2000
SYNTHES ANTERIOR CSLP SYSTEM
K000742 · KWQ
Synthes Spine
Orthopedic · 22d
Cleared Mar 29, 2000
MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT...
K992215 · DQA
Envitec-Wismar GmbH
Anesthesiology · 272d
Cleared Mar 29, 2000
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992554 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 243d
Cleared Mar 29, 2000
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
K993201 · KGO
Pamitex Industries Sdn Bhd
General Hospital · 187d
Cleared Mar 29, 2000
EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
K994026 · IYN
Hitachi Medical Corp. of America
Radiology · 124d
Cleared Mar 28, 2000
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
K000013 · DXT
Acist Medical Systems
Cardiovascular · 85d
Cleared Mar 28, 2000
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
K000495 · BSP
Ballard Medical Products
Anesthesiology · 42d
Cleared Mar 28, 2000
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR,...
K000660 · DRO
Medical Data Electronics
Cardiovascular · 29d
Cleared Mar 28, 2000
WESCO BLANKET
K981093 · DWJ
Wesco, Inc.
Cardiovascular · 733d
Cleared Mar 28, 2000
GAS FILTER
K993060 · JOD
Olson Medical Sales, Inc.
Cardiovascular · 197d
Cleared Mar 28, 2000
UCLA/UNIVERSAL ABUTMENT
K993129 · DZE
Diamodent
Dental · 190d
Cleared Mar 28, 2000
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
K993199 · CAF
Ferraris Medical, Inc.
Anesthesiology · 187d
Cleared Mar 28, 2000
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
K994194 · JBP
Cardiovascular Diagnostics, Inc.
Hematology · 106d
Cleared Mar 28, 2000
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
K994278 · CIN
Beckman Coulter, Inc.
Chemistry · 99d
Cleared Mar 28, 2000
AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
K994423 · DXN
Vsm Medtech , Ltd.
Cardiovascular · 90d
Cleared Mar 28, 2000
IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM
K994430 · MSX
General Electric Medical Systems...
Cardiovascular · 90d
Cleared Mar 27, 2000
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
K000060 · GDW
Senorx, Inc.
General & Plastic Surgery · 77d
Cleared Mar 27, 2000
RETIC CHEX LINEARITY
K000115 · JPK
Streck Laboratories, Inc.
Hematology · 73d
Cleared Mar 27, 2000
MFCD 118
K000291 · LLZ
Barco N.V.
Radiology · 56d
Cleared Mar 27, 2000
MFCD 120
K000294 · LLZ
Barco N.V.
Radiology · 56d
Cleared Mar 27, 2000
VENTRICULAR ANALYSIS TOOLKIT OPTION
K000315 · LNH
GE Medical Systems
Radiology · 55d
Cleared Mar 27, 2000
NOVA CORDLESS CURING LIGHT
K000393 · EBZ
Nova/Da Vinci Systems, Inc.
Dental · 49d