FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81577–81600 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2000
MICRO-MAX, MODEL 319
K002404 · IXW
Tek Marketing, Inc.
Radiology · 23d
Cleared Aug 30, 2000
TCD 100M, PWD13 TRANSDUCER
K002533 · IYN
Spencer Technologies
Radiology · 14d
Cleared Aug 30, 2000
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
K002535 · JJS
Bio-Rad
Chemistry · 14d
Cleared Aug 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
K002536 · JJS
Bio-Rad
Chemistry · 14d
Cleared Aug 30, 2000
OBC-096 BREAST ARRAY COIL
K002539 · MOS
Mri Devices Corp.
Radiology · 14d
Cleared Aug 30, 2000
MINOLTA PULSOX-3/MINOLTA PULSOX-3I
K984570 · DQA
In-X Corp.
Anesthesiology · 616d
Cleared Aug 30, 2000
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
K994283 · LNH
Medis Medical Imaging Systems BV
Radiology · 254d
Cleared Aug 29, 2000
AVID-NIT LOSS OF RESISTANCE SYRINGE
K001731 · FMF
Avid Medical, Inc.
General Hospital · 83d
Cleared Aug 29, 2000
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
K001903 · KPI
Neotonus, Inc.
Gastroenterology & Urology · 68d
Cleared Aug 29, 2000
DEPUY NEUFLEX PIP FINGER
K001922 · KYJ
Depuy, Inc.
Orthopedic · 67d
Cleared Aug 29, 2000
VECTOR TARGETING SYSTEM
K001938 · HSB
Vector Medical, Inc.
Orthopedic · 64d
Cleared Aug 29, 2000
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
K002138 · FPA
Maersk Medical A/S
General Hospital · 43d
Cleared Aug 29, 2000
PSI SKULL CLAMP
K002276 · HBL
V. Mueller Neuro/Spine
Neurology · 34d
Cleared Aug 29, 2000
MODULAR PORP AND TORP MODEL TBD
K002378 · ETA
Gyrus Ent LLC
Ear, Nose, Throat · 25d
Cleared Aug 29, 2000
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · MED
Advanced Sterilization Products
General Hospital · 22d
Cleared Aug 29, 2000
SMITH & NEPHEW OFF-CENTERED PORP
K002464 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 19d
Cleared Aug 28, 2000
INTRASTENT DOUBLESTRUT PARAMOUNT
K001648 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 28, 2000
IMPROVED TRY-IN GEL
K001899 · EBF
Sybron Dental Specialties, Inc.
Dental · 67d
Cleared Aug 28, 2000
RIGID GAS PERMEABLE CONTACT LENS
K001960 · HQD
Polymer Technology
Ophthalmic · 62d
Cleared Aug 28, 2000
FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN...
K991495 · FIP
Fluid Process Systems, Inc.
Gastroenterology & Urology · 488d
Cleared Aug 26, 2000
CERAMIX PORCELAIN SYSTEM
K000983 · EIH
C-Mix
Dental · 152d
Cleared Aug 26, 2000
FLUOROTEX II SURGICAL MESH
K002351 · FTL
Bridger Biomed, Inc.
General & Plastic Surgery · 24d
Cleared Aug 25, 2000
C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
K000354 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 203d
Cleared Aug 25, 2000
C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580
K000356 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 203d