Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
49393–49416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2010
EP NAVIGATOR R3
K101311 · LLZ
Philips Medical Systems North America...
Radiology · 142d
Cleared Sep 30, 2010
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
K101337 · IYO
Sonoscape Company Limited
Radiology · 141d
Cleared Sep 30, 2010
AIM 200, MAJOR SURGICAL LIGHT
K101537 · FSY
Burton Medical Products Corp.
General & Plastic Surgery · 119d
Cleared Sep 30, 2010
TSRH(R) SPINAL SYSTEM
K101772 · NKB
Medtronic Sofamor Danek
Orthopedic · 98d
Cleared Sep 30, 2010
SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
K102090 · OVD
Spine Smith Partners L.P.
Orthopedic · 66d
Cleared Sep 30, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
K102156 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 62d
Cleared Sep 30, 2010
CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
K102373 · LHN
Calypso Medical Technologies, Inc.
Radiology · 41d
Cleared Sep 30, 2010
PRIMALOK FACET FIXATION SYSTEM
K102438 · MRW
Osteomed LP
Orthopedic · 35d
Cleared Sep 30, 2010
ZOLL PROPAQ MD
K102468 · LDD
Zoll Medical Corporation, World Wide...
Cardiovascular · 31d
Cleared Sep 30, 2010
P200MAAF
K102492 · MYC
Optos Plc.
Ophthalmic · 30d
Cleared Sep 30, 2010
M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
K102495 · MHX
Philips Medical Systems
Cardiovascular · 30d
Cleared Sep 29, 2010
EBERLE SHAVER SYSTEM ACCESSORIES
K092977 · HRX
Efs Eberle Feinwerktechnische Systeme
Orthopedic · 369d
Cleared Sep 29, 2010
CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
K093834 · MSQ
Hema Metrics, LLC
Microbiology · 289d
Cleared Sep 29, 2010
FAT CONCENTRATION SYSTEM
K100114 · MUU
Biomet, Inc.
General & Plastic Surgery · 257d
Cleared Sep 29, 2010
DEPUY UNIVERSAL GRIPTION TF CONES
K100391 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 225d
Cleared Sep 29, 2010
C2000 POWERED WHEELCHAIR
K101524 · ITI
Otto Bock Healthcare LP
Physical Medicine · 119d
Cleared Sep 29, 2010
RELAY POWER WHEELCHAIR
K101611 · ITI
Dalton Instrument Corp.
Physical Medicine · 113d
Cleared Sep 29, 2010
CRYOBALLOON ABLATION SYSTEM
K101825 · GEH
C2 Therapeutics
General & Plastic Surgery · 90d
Cleared Sep 29, 2010
PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)
K101869 · EMA
Silmet , Ltd.
Dental · 89d
Cleared Sep 29, 2010
AMSINO I.V. ADMINISTRATION AND EXTENSION SETS
K101958 · FPA
Amsino International, Inc.
General Hospital · 79d
Cleared Sep 29, 2010
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
K102265 · KWQ
Ldr Spine USA
Orthopedic · 50d
Cleared Sep 28, 2010
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712
K091956 · OIY
Encore Medical, L.P.
Orthopedic · 454d
Cleared Sep 28, 2010
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
K093137 · NDY
Kamiya Biomedical Co.
Chemistry · 358d
Cleared Sep 28, 2010
SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA,...
K100112 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 257d