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
36241–36264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2014
PerkinElmer, XRpad 4343 F MED Flat Panel Detector
K142698 · MQB
Perkinelmer, Inc.
Radiology · 31d
Cleared Oct 23, 2014
Siemens 3.0 Blanket Array Coil
K142755 · MOS
Resonance Innovations, LLC
Radiology · 28d
Cleared Oct 23, 2014
LiNA PowerBlade Plus HC
K142757 · GEI
Lina Medical Aps
General & Plastic Surgery · 28d
Cleared Oct 23, 2014
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
K142876 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Oct 22, 2014
VANTERA CLINICAL ANALYZER
K133849 · NSU
Liposcience
Chemistry · 307d
Cleared Oct 22, 2014
UNIVERSAL DIGITAL INTERFACE 2, UDI 2
K140251 · MQB
Meridian Medical Systems, LLC
Radiology · 264d
Cleared Oct 22, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS
K141211 · NHA
Prismatik Dentalcraft, Inc.
Dental · 166d
Cleared Oct 22, 2014
SOLITAIRE 2 REVASCULARIZATION DEVICE
K141491 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 139d
Cleared Oct 22, 2014
ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM
K141544 · NHA
Zimmer Dental, Inc.
Dental · 134d
Cleared Oct 22, 2014
Ultra Silver Dressings
K141603 · FRO
Milliken Healthcare Products, LLC
General & Plastic Surgery · 128d
Cleared Oct 22, 2014
LIGHT SCALPEL
K141658 · GEX
Lightscalpel, LLC
General & Plastic Surgery · 124d
Cleared Oct 22, 2014
UPCERA COLORING LIQUID (I AND II )
K141723 · EIH
Liaoning Upcera Co., Ltd.
Dental · 118d
Cleared Oct 22, 2014
UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK
K141724 · EIH
Liaoning Upcera Co., Ltd.
Dental · 118d
Cleared Oct 22, 2014
DUAL SWITCH
K141908 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 99d
Cleared Oct 22, 2014
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
K142281 · HSB
Zimmer, Inc.
Orthopedic · 68d
Cleared Oct 22, 2014
Zimmer Periarticular Plating System
K142579 · HRS
Zimmer, Inc.
Orthopedic · 37d
Cleared Oct 22, 2014
VALOR Hindfoot Fusion Nail System
K142602 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 22, 2014
Vericore Zirconia Blanks
K142670 · EIH
Whip Mix Corporation
Dental · 33d
Cleared Oct 22, 2014
VERADIUS UNITY
K142708 · OWB
Philips Medical Systems Nethrlands BV
Radiology · 30d
Cleared Oct 21, 2014
PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
K140197 · CAC
Teleflexmedical, Inc.
Anesthesiology · 267d
Cleared Oct 21, 2014
CD HORIZON SPINAL SYSTEM
K141604 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 127d
Cleared Oct 21, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141651 · JWY
Thermo Fisher Scientific
Microbiology · 123d
Cleared Oct 21, 2014
JAGWIRE HIGH PERFORMANCE GUIDWIRE
K141820 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 106d
Cleared Oct 21, 2014
VIORA V-TOUCH
K141904 · GEI
Viora , Ltd.
General & Plastic Surgery · 99d