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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
43345–43368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2012
FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM...
K113775 · LOX
Ostial Corporation
Cardiovascular · 190d
Cleared Jun 29, 2012
ANY VIEW PATIENT MONITORS
K120193 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 158d
Cleared Jun 29, 2012
TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE...
K120218 · EFB
Palm Beach Dental Supply D/B/A Tek USA
Dental · 156d
Cleared Jun 29, 2012
ICTA
K120260 · OMB
Excel-Tech Ltd. (Xltek)
Neurology · 154d
Cleared Jun 29, 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K120459 · DYB
Oscor, Inc.
Cardiovascular · 135d
Cleared Jun 29, 2012
EXACTRAC ROBOTICS NOVALIS ROBOTICS
K120520 · JAI
Brainlab AG
Radiology · 129d
Cleared Jun 29, 2012
SC TIP CLEANER
K120581 · GEI
Nsi
General & Plastic Surgery · 123d
Cleared Jun 29, 2012
INTELLISPACE ECG
K120855 · DQK
Philips Health Care
Cardiovascular · 100d
Cleared Jun 29, 2012
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
K120897 · FTL
Sofradim Production
General & Plastic Surgery · 95d
Cleared Jun 29, 2012
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
K120963 · LYY
Medtexx Manufacturing Sdn. Bhd.
General Hospital · 91d
Cleared Jun 29, 2012
NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN...
K120990 · MBH
Zimmer Trabecular Metal Technology
Orthopedic · 88d
Cleared Jun 29, 2012
FLOWEASE [SUBCUTANEOUS] INFUSION SET
K121092 · FPA
Baxter Healthcare Corp
General Hospital · 80d
Cleared Jun 29, 2012
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
K121175 · LIT
Ostial Corporation
Cardiovascular · 72d
Cleared Jun 29, 2012
VERTEX RCCONSTRUCTION SYSTEM
K121191 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 71d
Cleared Jun 29, 2012
FUSE CAGE
K121288 · MAX
Advanced Medical Technologies AG
Orthopedic · 60d
Cleared Jun 29, 2012
WAVE O CAGE
K121330 · MAX
Advanced Medical Technologies AG
Orthopedic · 57d
Cleared Jun 29, 2012
LOOP CAGE
K121332 · MAX
Advanced Medical Technologies AG
Orthopedic · 57d
Cleared Jun 29, 2012
WAVE D CAGE
K121333 · MAX
Advanced Medical Technologies AG
Orthopedic · 57d
Cleared Jun 29, 2012
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
K121574 · JEY
Synthes, Inc.
Dental · 30d
Cleared Jun 29, 2012
INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM...
K121634 · FPA
Baxter Healthcare Corporation
General Hospital · 25d
Cleared Jun 29, 2012
SYSTEMS INTEGRATION
K121701 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 21d
Cleared Jun 28, 2012
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K103467 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 582d
Cleared Jun 28, 2012
ARCHITECT HAVAB-G
K113704 · LOL
Abbott Laboratories
Microbiology · 195d
Cleared Jun 28, 2012
MED-RX PATIENT DELIVERY SET
K120375 · FPA
Benlan, Inc.
General Hospital · 143d