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
104161–104184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1995
NEOSCREEN ELISA TSH
K942658 · JLW
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 263d
Cleared Feb 24, 1995
ULTIMAX POWDER FREE EXAMINATION GLOVES
K943451 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 221d
Cleared Feb 24, 1995
VISION SYSTEM UPPER G.I. EXDOSCOPE
K943715 · FDS
Vision-Sciences, Inc.
Gastroenterology & Urology · 207d
Cleared Feb 24, 1995
AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM
K944322 · LMD
At&T Image Solutions
Radiology · 175d
Cleared Feb 24, 1995
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
K944522 · IWJ
Medical Device Technologies, Inc.
Radiology · 161d
Cleared Feb 24, 1995
SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
K944753 · JWY
Radiometer America, Inc.
Microbiology · 151d
Cleared Feb 24, 1995
MATRICS IMPRESSION MATERIAL , SYSTEM
K944896 · ESD
Matrics, Inc.
Ear, Nose, Throat · 143d
Cleared Feb 24, 1995
CATCO NUTRITIONAL CATHETER
K945012 · KNT
Catco Medical, Inc.
Gastroenterology & Urology · 134d
Cleared Feb 24, 1995
TOUCH FOCUS 200MM DEFOCUSING HANDPIECE
K945178 · GEX
Plc Medical Systems, Inc.
General & Plastic Surgery · 123d
Cleared Feb 24, 1995
ACCU-BEAM C02 LASER HANDPIECE
K945648 · GEX
Tti Medical
General & Plastic Surgery · 99d
Cleared Feb 24, 1995
CAPNO-FLO(TM) REGULATOR
K945822 · CBP
Kirk Specialty Systems
Anesthesiology · 87d
Cleared Feb 24, 1995
CVD PERIFLOW(TM) BALLOON DILATATION CATHETER
K945943 · LIT
Cardio-Dynamics, Inc.
Cardiovascular · 81d
Cleared Feb 24, 1995
ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
K946029 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 77d
Cleared Feb 24, 1995
PHILIPPE CHARRIOL
K950193 · HQY
Philippe Charriol Dist., Inc.
Ophthalmic · 37d
Cleared Feb 24, 1995
LASERSPRAY(TM)
K950248 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 35d
Cleared Feb 24, 1995
KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS
K950338 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 28d
Cleared Feb 24, 1995
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
K950503 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 18d
Cleared Feb 24, 1995
50MM HANDPIECE
K950505 · GEX
Plc Medical Systems, Inc.
General & Plastic Surgery · 18d
Cleared Feb 24, 1995
NEEDLE/CANNULA
K950574 · LRO
Tri-Med Specialties, Inc.
General & Plastic Surgery · 28d
Cleared Feb 23, 1995
ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS
K921695 · ITX
Parker Laboratories, Inc.
Radiology · 1051d
Cleared Feb 23, 1995
VASOGENICS EECP-MC2
K940264 · DRN
Vasogenics, Inc.
Cardiovascular · 398d
Cleared Feb 23, 1995
INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS
K941487 · ESW
Instent, Inc.
Gastroenterology & Urology · 332d
Cleared Feb 23, 1995
MAKAR FULL AND HALF FACE SHIELD
K942828 · LYU
Instrument Makar, Inc.
General Hospital · 254d
Cleared Feb 23, 1995
COAT-A-COUNT(R) ESTRADIOL-6
K943193 · CHP
Diagnostic Products Corp.
Chemistry · 233d