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
70129–70152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2003
FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR
K032290 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 78d
Cleared Oct 10, 2003
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
K032310 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 74d
Cleared Oct 10, 2003
KLS-MARTIN STERNAL PLATING SYSTEM
K032413 · HRS
KLS-Martin L.P.
Orthopedic · 66d
Cleared Oct 10, 2003
MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
K032467 · KGO
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 60d
Cleared Oct 10, 2003
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
K032471 · LHQ
Titronics Research & Development Co.
Radiology · 60d
Cleared Oct 10, 2003
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K032577 · DQK
Ge Medical Systems Information...
Cardiovascular · 50d
Cleared Oct 10, 2003
GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
K032620 · IYN
General Electric Co.
Radiology · 45d
Cleared Oct 10, 2003
HL888BM
K032837 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Oct 10, 2003
HL888BA
K032839 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Oct 10, 2003
THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS,...
K032858 · DSI
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Oct 10, 2003
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
K032881 · CDZ
Diagnostic Products Corp.
Chemistry · 25d
Cleared Oct 10, 2003
RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
K032924 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 18d
Cleared Oct 10, 2003
ACCUSONIC A-SCAN MODEL, 24-4000
K032956 · IYO
Accutome, Inc.
Radiology · 18d
Cleared Oct 10, 2003
BRM2 BRAIN MONITOR
K033010 · OLT
Brainz Instruments , Ltd.
Neurology · 14d
Cleared Oct 10, 2003
MODIFICATION TO HL168
K033043 · DXN
Health & Life Co., Ltd.
Cardiovascular · 11d
Cleared Oct 10, 2003
ORTHOPHOS XG DS/CEPH
K033073 · EHD
Sirona Dental Systems GmbH
Radiology · 11d
Cleared Oct 10, 2003
KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
K033151 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Oct 10, 2003
HAC-12 AND HAC-30 HEAD ARRAY COIL
K033152 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Oct 10, 2003
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K033162 · JJY
Cliniqa Corporation
Chemistry · 10d
Cleared Oct 10, 2003
GE 0.2T SIGNA PROFILE/I MR SYSTEM
K033168 · LNH
General Electric Co.
Radiology · 10d
Cleared Oct 09, 2003
VELOPEX AQUACUT FLUID ABRASION UNIT
K024105 · KOJ
Velopex International, Inc.
Dental · 300d
Cleared Oct 09, 2003
EM PROBE, EM PAD
K024361 · ILY
Em Probe, Inc.
Physical Medicine · 283d
Cleared Oct 09, 2003
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 239d
Cleared Oct 09, 2003
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K031061 · MBH
Zimmer, Inc.
Orthopedic · 189d