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
154801–154824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 1983
PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH
K832374 · JOM
Sonicaid, Inc.
Cardiovascular · 136d
Cleared Dec 01, 1983
SHILEY M2000 MEMBRANE OXYGENATOR
K833253 · DTZ
Shiley, Inc.
Cardiovascular · 72d
Cleared Dec 01, 1983
NAMIC CONTINUOUS FLUSH DEVICE
K833271 · DRS
North American Instrument Corp.
Cardiovascular · 71d
Cleared Dec 01, 1983
AUDIT V AX 135
K833298 · GWK
Axonics, Inc.
Neurology · 69d
Cleared Dec 01, 1983
PREPARED MUELLER HINTON MED/100 MM
K833506 · JTZ
Lavco Laboratory, Inc.
Microbiology · 51d
Cleared Dec 01, 1983
PREPARED TRYPTIC SOY AGAR 100 MM PLATE
K833507 · JSG
Lavco Laboratory, Inc.
Microbiology · 51d
Cleared Dec 01, 1983
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
K833798 · DXY
Telectronics, Inc.
Cardiovascular · 31d
Cleared Dec 01, 1983
NEURAL STIMULATOR MONITOR
K833809 · GZB
Instromedix, Inc.
Neurology · 29d
Cleared Dec 01, 1983
HOLTER PERFORMER FEATHER WEIGHT/CASS
K833823 · DSH
Applied Cardiac Systems
Cardiovascular · 29d
Cleared Dec 01, 1983
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824 · DTB
Pacesetter Systems
Cardiovascular · 31d
Cleared Nov 30, 1983
SOLUTION ADMINISTRATION LINE W/SPIKE
K833178 · FPA
Intramed, Inc.
General Hospital · 72d
Cleared Nov 29, 1983
TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS
K830197 · KLK
Diamond Shamrock Corp.
Anesthesiology · 313d
Cleared Nov 29, 1983
MBS HARD TISSUE REPLACEMENT SYSTEM
K832509 · LYC
Medical Biological Sciences, Inc.
Dental · 125d
Cleared Nov 29, 1983
SYSTENET
K832544 · KGX
American Intl. Medical Supply Co.
General & Plastic Surgery · 123d
Cleared Nov 29, 1983
WINDSOR MEDICAL VARIOUS MODELS
K832606 · FRN
Windsor Medical, Inc.
General Hospital · 118d
Cleared Nov 29, 1983
POINTER F-3
K833037 · GZJ
Petra Intl. Co.
Neurology · 83d
Cleared Nov 29, 1983
HOBBS MEDICAL RETRIEVAL BASKET
K833124 · OCZ
Hobbs Medical, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 29, 1983
TRICON M TOTAL KNEE SYSTEM
K833200 · MBV
Richards Medical Co., Inc.
Orthopedic · 71d
Cleared Nov 29, 1983
BIFOCAL 3.0MHZ
K833224 · ITX
Adr Ultrasound
Radiology · 84d
Cleared Nov 29, 1983
TELEPHONE TRANSMITTER T-10 EEG
K833236 · GYE
Pharmaquest Corp.
Radiology · 105d
Cleared Nov 29, 1983
REVIVE
K833244 · BTM
Aladdin Industries, Inc.
Anesthesiology · 70d
Cleared Nov 29, 1983
3M SCOTCHPLATE II DISPERSIVE ELECTRODE
K833364 · GEI
3M Company
General & Plastic Surgery · 62d
Cleared Nov 29, 1983
DRY GEL
K833441 · GEI
Concept, Inc.
General & Plastic Surgery · 55d
Cleared Nov 29, 1983
HAND CONTROLLED PENCIL OR SWITCH HAND
K833449 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 55d