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.

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

Filters: Cleared only ×
175,230 results
146305–146328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1985
OMNI PLANE SYSTEM
K854085 · IXR
Xre Corp.
Radiology · 21d
Cleared Oct 28, 1985
THE CSE FILM CHANGER SYSTEM
K854251 · IZP
Changer Service & Engineering, Inc.
Radiology · 6d
Cleared Oct 25, 1985
LACTOPLATE
K852737 · DEG
Mackeen Consultants, Ltd.
Immunology · 120d
Cleared Oct 25, 1985
ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA-
K853874 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 38d
Cleared Oct 25, 1985
ENDO-LASE CD40 FOR UROLOGY
K853904 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 35d
Cleared Oct 25, 1985
MICROVASIVE SILICONE SPRAY
K854063 · KCT
Microvasive
General Hospital · 21d
Cleared Oct 25, 1985
NML TSH IRMA
K854087 · JLW
Organon Teknika Corp.
Chemistry · 18d
Cleared Oct 25, 1985
DMA CALIBRATORS
K854092 · JIX
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Oct 25, 1985
ACCURACY
K854119 · JJY
Columbia Diagnostics, Inc.
Chemistry · 16d
Cleared Oct 24, 1985
DIAGNOSTIC ECG DISPOSABLE ELECTRODE
K851522 · DRX
Sentry Medical Products, Inc.
Cardiovascular · 192d
Cleared Oct 24, 1985
FREEDOM LINE LUBRICATED MODELS LS-2-5, LT-6-10
K852816 · EIA
Apollo Dental Products, Inc.
Dental · 114d
Cleared Oct 24, 1985
ACUSON RADIOLOGY DOPPLER ACCESSORY
K852974 · ITX
Acuson Computed Sonography
Radiology · 101d
Cleared Oct 24, 1985
LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03
K853519 · DTB
Intermedics, Inc.
Cardiovascular · 63d
Cleared Oct 24, 1985
TOP SUN MODELS 100,101,103 &139, 139-1, 139-3
K853833 · FTC
Top Sun America, Inc.
General & Plastic Surgery · 38d
Cleared Oct 24, 1985
CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105
K853861 · IJZ
Canon USA, Inc.
Radiology · 37d
Cleared Oct 23, 1985
MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417
K850165 · JOP
Hoffrel Instruments, Inc.
Cardiovascular · 280d
Cleared Oct 23, 1985
COMPANION 2800 VOLUME VENTILATOR
K851366
Puritan Bennett Corp.
Cardiovascular · 201d
Cleared Oct 23, 1985
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
K851889 · BZQ
Clinical Data, Inc.
Anesthesiology · 176d
Cleared Oct 23, 1985
750 SD ULTRASOUND SCANNER(MODIFICATION)
K851901 · DXK
Ultrasonix, Inc.
Cardiovascular · 176d
Cleared Oct 23, 1985
OCS-2 COLPOSCOPE
K852980 · HEX
Olympus Corp.
Obstetrics & Gynecology · 100d
Cleared Oct 23, 1985
E-Z-GUARD MOUTHPIECE
K853402 · BYP
E-Z-Em, Inc.
Anesthesiology · 72d
Cleared Oct 23, 1985
COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI
K853590 · DXY
Cook Pacemaker Corp.
Cardiovascular · 56d
Cleared Oct 23, 1985
COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER
K853651 · DXY
Cook Pacemaker Corp.
Cardiovascular · 50d
Cleared Oct 23, 1985
VEDLAR VENTILATOR (MODIFICATION)
K854026
Hamilton Medical, Inc.
Cardiovascular · 58d