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
90841–90864 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1998
VANISHPOINT SYRINGE
K980069 · MEG
Retractable Technologies, Inc.
General Hospital · 35d
Cleared Feb 12, 1998
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY
K980178 · JJY
Bionostics, Inc.
Chemistry · 23d
Cleared Feb 12, 1998
2700 SAMPLE MANAGER
K980180 · JQW
Waters Corporation
Toxicology · 23d
Cleared Feb 12, 1998
SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
K980205 · JHI
San Diego Biotech
Chemistry · 23d
Cleared Feb 12, 1998
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
K980316 · CJE
Diagnostic Chemicals , Ltd.
Chemistry · 16d
Cleared Feb 11, 1998
ENSEMBLE CENTRAL STATION MONITOR
K970358 · DSI
Mennen Medical, Inc.
Cardiovascular · 377d
Cleared Feb 11, 1998
MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING
K971206 · LPH
Howmedica Corp.
Orthopedic · 336d
Cleared Feb 11, 1998
PHASED ARRAY TRANSDUCER - - PVF -375DT
K972771 · ITX
Toshiba America Medical Systems, In.C
Radiology · 202d
Cleared Feb 11, 1998
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS
K972856 · KNF
Rocket Medical Plc
Obstetrics & Gynecology · 194d
Cleared Feb 11, 1998
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION
K973827 · KCT
Kimberly-Clark Corp.
General Hospital · 127d
Cleared Feb 11, 1998
VERSASTAT MULTIPOLAR SCISSORS AND CABLES
K974250 · GEI
Pilling Weck, Inc.
General & Plastic Surgery · 90d
Cleared Feb 11, 1998
0.2 U BACTERIAL FILTER
K974661 · FPB
Sims Deltec, Inc.
General Hospital · 58d
Cleared Feb 11, 1998
POWDERFREE LATEX EXAMINATION GLOVES
K974832 · LYY
Servicom Services Sdn Bhd
General Hospital · 49d
Cleared Feb 10, 1998
CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)
K973225 · FLE
Getinge/Castle, Inc.
General Hospital · 167d
Cleared Feb 10, 1998
MASKY
K973542 · EBI
Pressing DI Monticelli Rag. Stefano
Dental · 145d
Cleared Feb 10, 1998
PALJET-B
K973663 · DRX
Golden Gate Bio-Device
Cardiovascular · 138d
Cleared Feb 10, 1998
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM
K973867 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 141d
Cleared Feb 10, 1998
CES MASSTRANSIT INFUSION CATHETER
K974222 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 90d
Cleared Feb 10, 1998
LS-905 FIBERCHOICE ADAPTER SYSTEM
K974229 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 90d
Cleared Feb 10, 1998
AMPLAID AM50
K974235 · ETY
Amplifon S.P.A.
Ear, Nose, Throat · 90d
Cleared Feb 10, 1998
GSI 70 AUDIOPATH SCREENER
K974237 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 90d
Cleared Feb 10, 1998
AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM
K974239 · IXI
Aktina Medical Physics Corp.
Radiology · 90d
Cleared Feb 10, 1998
40 CC GRANDE
K974247 · DSP
Boston Scientific Corp
Cardiovascular · 90d
Cleared Feb 10, 1998
FM RECEIVER - AUDITORY TRAINER
K974287 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 88d