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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73777–73800 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2002
EASY LIFE
K023521 · INO
Berkline Corp.
Physical Medicine · 29d
Cleared Nov 19, 2002
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K023570 · MQP
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Nov 19, 2002
STORM TDX POWER WHEELCHAIR
K023589 · ITI
Invacare Corp.
Physical Medicine · 25d
Cleared Nov 19, 2002
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
K023601 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 22d
Cleared Nov 19, 2002
TILITE YG AND TILITE YGS
K023606 · IOR
Tisport
Physical Medicine · 22d
Cleared Nov 19, 2002
BIOBUCK CEMENT RESTRICTOR
K023680 · LZN
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Nov 19, 2002
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O
K023698 · MHX
Philips Medical Systems
Cardiovascular · 15d
Cleared Nov 19, 2002
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
K023749 · DRG
Philips Medical Systems
Cardiovascular · 11d
Cleared Nov 18, 2002
RENAX HEMODIALYSIS BLOOD TUBING SET
K014140 · FJK
Sunder Biomedical Tech. Co., Ltd.
Gastroenterology & Urology · 336d
Cleared Nov 18, 2002
BAXTER ACCURA SYSTEM, MODEL 5M5660
K021615 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 186d
Cleared Nov 18, 2002
IDI-STREP B ASSAY
K022504 · NJR
Infectio Diagnostic, Inc.
Microbiology · 112d
Cleared Nov 18, 2002
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
K022671 · LZA
Hartalega Sdn Bhd
General Hospital · 98d
Cleared Nov 18, 2002
MILLENNIUM MICROSURGICAL SYSTEM
K022760 · GEX
Bausch & Lomb, Inc.
General & Plastic Surgery · 90d
Cleared Nov 18, 2002
AMEDITECH IMMUTEST HCG PREGANCY TEST
K023126 · LCX
Ameditech, Inc.
Chemistry · 60d
Cleared Nov 18, 2002
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K023184 · DIC
Bayer Diagnostics Corp.
Chemistry · 55d
Cleared Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310,...
K023337 · KTI
Boston Scientific Corp
Ear, Nose, Throat · 42d
Cleared Nov 18, 2002
SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN
K023635 · FYA
Sri/Surgical Express, Inc.
General Hospital · 20d
Cleared Nov 18, 2002
GORE 3.0T TORSO ARRAY
K023679 · MOS
W.L. Gore & Associates, Inc.
Radiology · 17d
Cleared Nov 15, 2002
VITALSAT SERIES
K011518 · DQA
Beta Biomed Services, Inc.
Anesthesiology · 547d
Cleared Nov 15, 2002
CALGITROL AG SILVER ALGINATE WOUND DRESSING
K011618 · FRO
Adri
General & Plastic Surgery · 539d
Cleared Nov 15, 2002
PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K013913 · NFA
Medtronic Percusurge, Inc.
Cardiovascular · 353d
Cleared Nov 15, 2002
ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE,...
K022821 · DZK
Ideatrics, Inc.
Dental · 81d
Cleared Nov 15, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
K022982 · HNO
Med-Logics, Inc.
Ophthalmic · 67d
Cleared Nov 15, 2002
HERMES OPERATING ROOM CONTROL CENTER
K023095 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 58d