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
74233–74256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2002
7.0 FR. ENDOBRONCHIAL BLOCKER
K021920 · CBI
Cook, Inc.
Anesthesiology · 64d
Cleared Aug 14, 2002
RHIGENE MESACUP-2 TEST RNP, MODEL M7741
K022017 · LKO
Rhigene, Inc.
Immunology · 55d
Cleared Aug 14, 2002
REGISTRADO X-TRA
K022066 · ELW
Voco GmbH
Dental · 50d
Cleared Aug 14, 2002
INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
K022242 · DSY
Intervascular
Cardiovascular · 34d
Cleared Aug 14, 2002
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
K022270 · ODA
Olympus Optical Co., Ltd.
Radiology · 30d
Cleared Aug 14, 2002
STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
K022414 · HAW
Medtronic Surgical Navigation...
Neurology · 21d
Cleared Aug 14, 2002
SCREWLINE
K022425 · DZE
Altatec Biotechnologies N.A., Inc.
Dental · 21d
Cleared Aug 14, 2002
507EL VITAL SIGNS MONITOR
K022435 · DRT
Criticare Systems, Inc.
Cardiovascular · 20d
Cleared Aug 14, 2002
K-ASSAY HS-CRP CONTROLS
K022486 · DCK
Kamiya Biomedical Co.
Immunology · 16d
Cleared Aug 13, 2002
ELECTROPHYSIOLOGY CATHETER
K012708 · NLH
Alliance Medical Corp.
Cardiovascular · 364d
Cleared Aug 13, 2002
CERALAS D DIODE LASER SYSTEM, MODEL # D50
K013691 · GEX
Biolitec, Inc.
General & Plastic Surgery · 279d
Cleared Aug 13, 2002
GLOVCO EBONY
K013828 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 267d
Cleared Aug 13, 2002
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
K020655 · LZG
Deltec, Inc.
General Hospital · 165d
Cleared Aug 13, 2002
7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630...
K020759 · BZD
Hans Rudolph, Inc.
Anesthesiology · 159d
Cleared Aug 13, 2002
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
K021573 · CBK
Puritan-Bennett
Anesthesiology · 91d
Cleared Aug 13, 2002
96 CHANNEL EEG HEADBOX MODEL EMU96
K021599 · GWQ
Excel Tech. , Ltd.
Neurology · 90d
Cleared Aug 13, 2002
ISA-21 INTERVENTIONAL SPINE ARRAY COIL
K021631 · MOS
Mri Devices Corp.
Radiology · 88d
Cleared Aug 13, 2002
MHS MED LIGHT 1000
K021956 · ILY
Micro Health Systems, Inc.
Physical Medicine · 61d
Cleared Aug 13, 2002
GRIPPER PLUS NEEDLE
K021999 · FPA
Deltec, Inc.
General Hospital · 55d
Cleared Aug 13, 2002
SPHERZ
K022074 · HAW
I.Z.I. Corp.
Neurology · 48d
Cleared Aug 13, 2002
SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
K022197 · GXY
The Electrode Store, Inc.
Neurology · 39d
Cleared Aug 13, 2002
MODIFICATION TO ISOLA SPINAL SYSTEM
K022285 · MNI
Depuyacromed
Orthopedic · 29d
Cleared Aug 13, 2002
EMS PIEZON MASTER 600
K022328 · ELC
Electro Medical Systems SA
Dental · 26d
Cleared Aug 13, 2002
3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
K022337 · IZL
Siemens Medical Solutions USA, Inc.
Radiology · 26d