FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123601–123624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1991
DYNAPULSE 200M
K904739 · DXN
Pulse Metric, Inc.
Cardiovascular · 82d
Cleared Jan 08, 1991
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
K904741 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 82d
Cleared Jan 08, 1991
IN-LINE ATS BLOOD RECOVERY BAG
K904794 · CAC
Atrium Medical Corp.
Anesthesiology · 77d
Cleared Jan 08, 1991
ADJUSTABLE PEEP VALVE
K904874 · BYE
Vital Signs, Inc.
Anesthesiology · 70d
Cleared Jan 08, 1991
PARADERM(TM) SURGEON'S GLOVE ACCESSORY
K904903 · LYU
Lovell-Schenck, Inc.
General Hospital · 71d
Cleared Jan 08, 1991
MODEL 3100-64: QUADRATURE SPINE COIL
K905104 · LNH
Medical Advances, Inc.
Radiology · 56d
Cleared Jan 08, 1991
LOBOW
K905250 · LIT
Perinatal Systems
Cardiovascular · 48d
Cleared Jan 08, 1991
MICRO-AIRE 4220-000 OSCILLATING SAW
K905277 · HSZ
Micro Surgical Instruments Corp.
Orthopedic · 46d
Cleared Jan 08, 1991
KUDO (POWERED ROTATION BED)
K905390 · IKZ
Kinetic Concepts, Inc.
Physical Medicine · 39d
Cleared Jan 08, 1991
TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE
K905756 · JFB
Titan Technology Intl., Inc.
Physical Medicine · 12d
Cleared Jan 07, 1991
REDI-RELEASE ABSORBENT DRESSING
K904604 · KOZ
Fountain Pharmaceuticals, Inc.
General & Plastic Surgery · 89d
Cleared Jan 07, 1991
CENTAURI YAG LASER SYST, EAR, NOSE , THROAT
K904627 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 90d
Cleared Jan 07, 1991
CENTAURI YAG LASER SYST, GASTROENTEROLOGY
K904628 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 90d
Cleared Jan 07, 1991
CENTAURI YAG LASER SYST, UROLOGY
K904629 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 90d
Cleared Jan 04, 1991
HA-TI (HAND-TITANIUM SCREW) IMPLANT
K901927 · DZE
Mathys Corp. of North America
Dental · 249d
Cleared Jan 04, 1991
CONTAIN(TM) LASER PLUME FILTER
K902167 · JDY
Arbor Technologies, Inc.
Orthopedic · 234d
Cleared Jan 04, 1991
MODEL 295 ELECTRONIC RESPIROMETER
K903674 · BZK
National Medical Sales, Inc.
Anesthesiology · 144d
Cleared Jan 04, 1991
C FIT CUP
K903938 · JDI
Orthopedic Systems, Inc.
Orthopedic · 130d
Cleared Jan 04, 1991
A2J TELEMETER
K904127 · IWE
A2j, Inc.
Radiology · 128d
Cleared Jan 04, 1991
STARCAM 4000
K904174 · IYX
General Electric Co.
Radiology · 116d
Cleared Jan 04, 1991
BIOPRO TRINITY ACETABULAR CUP
K904207 · JDI
Biopro, Inc.
Orthopedic · 114d
Cleared Jan 04, 1991
ELECTROSURGICAL PENCIL
K904808 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 72d
Cleared Jan 04, 1991
TRANSDUCER PROTECTOR
K904912 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 04, 1991
VARIOUS AFTERLOADING APPLICATORS
K904933 · IWJ
Best Assoc. Corp.
Radiology · 64d