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
83281–83304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2000
INTER-OS BONE GENERATOR
K993869 · MQN
Inter-Os Technologies, LLC
Dental · 65d
Cleared Jan 18, 2000
MULTIFUNCTION KEITO K5
K984083 · DXN
Bumedco Intl., Inc.
Cardiovascular · 428d
Cleared Jan 18, 2000
LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
K990445 · ISA
Lpg USA, Inc.
Physical Medicine · 342d
Cleared Jan 18, 2000
1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING...
K991390 · MQL
Sage Biopharma
Obstetrics & Gynecology · 272d
Cleared Jan 18, 2000
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC...
K991861 · BTM
Sims Portex, Inc.
Anesthesiology · 231d
Cleared Jan 18, 2000
3.0 ML RESERVOIR, MODEL 103/193
K991936 · FRN
Medtronic Minimed
General Hospital · 223d
Cleared Jan 18, 2000
V.A.C. PLUS
K992448 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 180d
Cleared Jan 18, 2000
A-22 HEMODIALYZER
K992563 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
AF-180 HEMODIALYZER
K992564 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
AF-150 HEMODIALYZER
K992566 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
AF-220 HEMODIALYZER
K992573 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
OSOM ULTRA STREP A TEST, MODEL 147
K992658 · GTY
Wyntek Diagnostics, Inc.
Microbiology · 162d
Cleared Jan 18, 2000
THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM
K992727 · KIF
Mds
Dental · 158d
Cleared Jan 18, 2000
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K992811 · HFM
Epic Medical Equipment Services, Inc.
Radiology · 151d
Cleared Jan 18, 2000
GYNECARE VERSAPOINT G-VAP ELECTRODE
K992901 · HIH
Gynecare, Inc.
Obstetrics & Gynecology · 141d
Cleared Jan 18, 2000
STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
K993239 · HAW
Stryker Corp.
Neurology · 113d
Cleared Jan 18, 2000
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
K993574 · LNH
Toshiba America Mri, Inc.
Radiology · 89d
Cleared Jan 18, 2000
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL...
K993599 · LMA
Vidar Systems Corp.
Radiology · 85d
Cleared Jan 18, 2000
FAS ENDOLUMINAL BRUSH
K993614 · LJS
Fas Medical , Ltd.
General Hospital · 85d
Cleared Jan 18, 2000
RENAMEL SCULPT
K993658 · EBF
Cosmedent, Inc.
Dental · 81d
Cleared Jan 18, 2000
RENAMEL PACK
K993659 · EBF
Cosmedent, Inc.
Dental · 81d
Cleared Jan 18, 2000
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
K993720 · KNQ
Cordis Corp.
Gastroenterology & Urology · 76d
Cleared Jan 18, 2000
SHARPVIEW IMAGE ENHANCEMENT SYSTEM
K993802 · LLZ
Context Vision AB
Radiology · 70d
Cleared Jan 18, 2000
LUMAGEM SCINTILLATION CAMERA
K993813 · IYX
Gamma Medica
Radiology · 69d