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
82897–82920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2000
ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
K994014 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 90d
Cleared Feb 24, 2000
HORTMANN ECHOMASTER OAE ANALYZER
K994033 · EWO
Hortmann AG
Ear, Nose, Throat · 90d
Cleared Feb 24, 2000
7250 (MEGAS)
K994369 · IYN
Biosound Esaote, Inc.
Radiology · 59d
Cleared Feb 23, 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K000002 · MOS
Usa Instruments, Inc.
Radiology · 51d
Cleared Feb 23, 2000
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210 · DTD
Medtronic Vascular
Cardiovascular · 30d
Cleared Feb 23, 2000
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
K000257 · JFH
Diagnostic Products Corp.
Immunology · 27d
Cleared Feb 23, 2000
ACCU-CHEK COMPLETE METER
K000364 · LFR
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Feb 23, 2000
ACCU-CHEK ADVANTAGE METER
K000365 · CGA
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Feb 23, 2000
EXEL INJECTION PLUG WITH CAP
K992290 · FPA
Exel Intl.
General Hospital · 231d
Cleared Feb 23, 2000
SYNTHETIC VDRL ANTIGEN
K993633 · GMQ
Centers For Disease Control and...
Microbiology · 119d
Cleared Feb 23, 2000
PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
K994182 · LBH
Pulpdent Corp.
Dental · 75d
Cleared Feb 23, 2000
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY...
K994318 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 63d
Cleared Feb 23, 2000
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY...
K994324 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 63d
Cleared Feb 23, 2000
IMMUNOCYT
K994356 · NBK
Diagnocure, Inc.
Pathology · 62d
Cleared Feb 23, 2000
SNN STEREOTAXIC PLANNING APPLICATION
K994421 · HAW
Surgical Navigation Specialists, Inc.
Neurology · 56d
Cleared Feb 22, 2000
SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES
K000166 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 34d
Cleared Feb 22, 2000
ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND
K000228 · GEI
Arthrocare Corp.
General & Plastic Surgery · 26d
Cleared Feb 22, 2000
10 CURIE IRDIUM 192, CSN00100-192
K991571 · KXK
Alpha-Omega Services, Inc.
Radiology · 293d
Cleared Feb 22, 2000
OXYCON PRO
K992214 · BZC
Erich Jaeger B.V.
Anesthesiology · 236d
Cleared Feb 22, 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992461 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 214d
Cleared Feb 22, 2000
PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED...
K992537 · FTM
Bio-Vascular, Inc.
General & Plastic Surgery · 208d
Cleared Feb 22, 2000
LEMAITRE BALLOON CATHETER WITH IRRIGATION
K992940 · DXE
Vascutech, Inc.
Cardiovascular · 175d
Cleared Feb 22, 2000
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
K993974 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d
Cleared Feb 22, 2000
PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM...
K993976 · KPI
The Prometheus Group
Gastroenterology & Urology · 90d