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
169801–169824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 1979
SOLVENT DELIVERY SYSTEM
K790145 · KIE
Waters Assoc., Inc.
Toxicology · 28d
Cleared Feb 15, 1979
COLLIMATOR, BILATERIAL
K790168 · KQA
Cmsi
Radiology · 23d
Cleared Feb 15, 1979
TOMOGRAPHIC PROGRAMS
K790169 · KPS
Cmsi
Radiology · 23d
Cleared Feb 15, 1979
2 VELCRO SPLINT STRAP
K790182 · ILH
Fred Sammons, Inc.
Physical Medicine · 20d
Cleared Feb 13, 1979
PULMONARY MONITOR
K781922 · BZH
Vitalograph , Ltd.
Anesthesiology · 92d
Cleared Feb 13, 1979
NEEDLES, CANNULAS, CYSTOTOMES
K782169 · HMX
Visitec Co.
Ophthalmic · 46d
Cleared Feb 13, 1979
MONITOR, PRESSURVEIL
K790135 · DSK
Concept, Inc.
Cardiovascular · 22d
Cleared Feb 13, 1979
BK-1472 SPATULA SPOON
K790170 · ILC
Fred Sammons, Inc.
Physical Medicine · 18d
Cleared Feb 13, 1979
PLATFORM SPLINTS
K790180 · ILH
Fred Sammons, Inc.
Physical Medicine · 18d
Cleared Feb 13, 1979
SOFT SPLINT STRAPS
K790181 · ILH
Fred Sammons, Inc.
Physical Medicine · 18d
Cleared Feb 13, 1979
STERILE DISPOSABLE KNIFE
K790259 · GDX
Intermedics, Inc.
General & Plastic Surgery · 7d
Cleared Feb 13, 1979
UNIVERSAL EXTERNAL FIXATION ASSEMBLY
K790262 · JEC
Zimmer, Inc.
Orthopedic · 7d
Cleared Feb 13, 1979
LEVO-STAND-UP WHEELCHAIR
K790265 · IPL
Marion Laboratories, Inc.
Physical Medicine · 7d
Cleared Feb 12, 1979
BEAVER CATARACT CYROXTRACTOR
K781338 · HPS
Edward Weck, Inc.
Ophthalmic · 192d
Cleared Feb 12, 1979
AUTOKERATOMETER, INSTRUMENT
K781994 · HLQ
Zeiss Humphrey System
Ophthalmic · 75d
Cleared Feb 12, 1979
REMOVER, SOFT-SERT CONTACT LENS
K782140 · KYE
Mcmurray and Pendergost
Ophthalmic · 47d
Cleared Feb 12, 1979
OCCULAR COMPU-SCAN
K790023 · IYO
Storz Instrument Co.
Radiology · 40d
Cleared Feb 12, 1979
MODEL 556-01 CRYOEXTRACTOR
K790102 · HPS
Intermedics, Inc.
Ophthalmic · 27d
Cleared Feb 12, 1979
TINNITUS MASKERS MODEL S584
K790190 · KLW
Vican Instrument Co.
Ear, Nose, Throat · 17d
Cleared Feb 12, 1979
VENTILATION TUBE, SHEEHY COLLAT
K790216 · ETD
Xomed, Inc.
Ear, Nose, Throat · 13d
Cleared Feb 12, 1979
EARETTE HEARING AID
K790228 · ESD
Oticon Corp.
Ear, Nose, Throat · 10d
Cleared Feb 12, 1979
TRANSVERSE TRACTION ASSEMBLY
K790238 · KWP
Zimmer, Inc.
Orthopedic · 11d
Cleared Feb 12, 1979
CANNULAS
K790243 · HMX
Visitec Co.
Ophthalmic · 45d
Cleared Feb 12, 1979
CYSTOTOMES
K790244 · HNY
Visitec Co.
Ophthalmic · 45d