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
104281–104304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1995
VIVAGLASS BASE
K950428 · EMA
Ivoclar North America, Inc.
Dental · 15d
Cleared Feb 16, 1995
FOCUS RTP
K915691 · MUJ
Computerized Medical Systems, Inc.
Radiology · 1151d
Cleared Feb 16, 1995
IORT SYSTEM
K933117 · IYE
Northwest Medical Physics Center
Radiology · 601d
Cleared Feb 16, 1995
FAS FASTIDIOUS MIC PANEL
K935485 · JWY
Microtech Medical Systems, Inc.
Microbiology · 458d
Cleared Feb 16, 1995
DRIED GRAM-NEGATIVE CEFPODOXIME
K941030 · LTT
Baxter Diagnostics, Inc.
Microbiology · 349d
Cleared Feb 16, 1995
DIAL MEDICAL KIT
K941543 · KOC
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 323d
Cleared Feb 16, 1995
40 MICRON BLOOD TRANSFUSION FILTER
K941628 · FPB
Douglas Medical Products Corp.
General Hospital · 318d
Cleared Feb 16, 1995
CARBON DIOXIDE ANALYZER (MODEL CD-3A)
K942113 · CCK
Ametek, Inc.
Anesthesiology · 290d
Cleared Feb 16, 1995
HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE
K942842 · DQA
Hewlett-Packard GmbH
Anesthesiology · 245d
Cleared Feb 16, 1995
KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM
K944847 · JSL
Starplex Scientific, Inc.
Microbiology · 139d
Cleared Feb 16, 1995
PARRALLEL PIN
K944904 · DZE
"O" Co., Inc.
Dental · 134d
Cleared Feb 16, 1995
CATCO URINARY COLLECTION KIT
K945258 · FCN
Catco Medical, Inc.
Gastroenterology & Urology · 111d
Cleared Feb 16, 1995
ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT
K945300 · DZE
"O" Co., Inc.
Dental · 108d
Cleared Feb 16, 1995
BARIKARE PLUS
K945664 · FNL
Kinetic Concepts, Inc.
General Hospital · 91d
Cleared Feb 16, 1995
CONTINUOUS EPIDURAL ANESTHESIA TRAY
K945671 · CAZ
Trinity Laboratories, Inc.
Anesthesiology · 90d
Cleared Feb 16, 1995
MODIFIED FOX EXTRA GRAM POSITIVE
K945997 · JWY
Micro-Media Systems, Inc.
Microbiology · 132d
Cleared Feb 16, 1995
ORALVUE DENTAL MIRROR
K946073 · EAX
Hines Group , Ltd.
Dental · 71d
Cleared Feb 16, 1995
MILL-ROSE SCOPE CLEANING BRUSH
K946293 · MNL
Mill-Rose Laboratory
Gastroenterology & Urology · 51d
Cleared Feb 16, 1995
HARRY J. BOSWORTH RESIN I.
K946317 · EBI
Harry J. Bosworth Co.
Dental · 50d
Cleared Feb 16, 1995
EAGLE
K950309 · EJI
Aalba Dent, Inc.
Dental · 22d
Cleared Feb 16, 1995
ENDURE
K950310 · EJT
Aalba Dent, Inc.
Dental · 22d
Cleared Feb 16, 1995
DIENER RETRIEVAL DEVICES
K950559 · FCL
Mill-Rose Laboratory
Gastroenterology & Urology · 8d
Cleared Feb 15, 1995
MULTILEAF INTENSITY MODULATING COLLIMATOR
K940412 · IXI
Nomos Corp.
Radiology · 384d
Cleared Feb 15, 1995
PANASONIC WRIST BLOOD PRESSURE METER
K942422 · DXN
King & Spalding
Cardiovascular · 271d