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
84361–84384 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1999
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN...
K991906 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 186d
Cleared Nov 23, 1999
ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
K992235 · LZO
Corin USA
Orthopedic · 144d
Cleared Nov 23, 1999
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K992330 · JEY
Biomedics
Dental · 134d
Cleared Nov 23, 1999
CIDEX OPA SOLUTION TEST STRIP
K992341 · JOJ
Serim Research Corp.
General Hospital · 133d
Cleared Nov 23, 1999
AMORPHOUS DIAMOND COATED SCREW
K992538 · DZE
Nobel Biocare Uas, Inc.
Dental · 116d
Cleared Nov 23, 1999
ROCHE COBAS INTEGRA OPIATES 300/2000
K992890 · DJG
Roche Diagnostics Corp.
Toxicology · 88d
Cleared Nov 23, 1999
EBI SPINELINK SYSTEM
K992920 · MNI
Ebi, L.P.
Orthopedic · 85d
Cleared Nov 23, 1999
AX WORKSTATION DR-VIEWER SOFTWARE OPTION
K992925 · LLZ
Siemens Corp.
Radiology · 85d
Cleared Nov 23, 1999
TURBO 7000 SHAVER AND DRILL CONSOLE
K992994 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 77d
Cleared Nov 23, 1999
STERILE HYDROGEL
K993119 · MGQ
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 64d
Cleared Nov 23, 1999
HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
K993128 · CGA
Health Hero Network, Inc.
Chemistry · 64d
Cleared Nov 23, 1999
K-ASSAY IGA
K993213 · CFF
Kamiya Biomedical Co.
Immunology · 60d
Cleared Nov 23, 1999
N LATEX FERRITIN
K993273 · DBF
Dade Behring, Inc.
Immunology · 54d
Cleared Nov 23, 1999
PIONEER SILICOAT STERNAL CABLE
K993286 · JDQ
Pioneer Surgical Technology
Orthopedic · 53d
Cleared Nov 23, 1999
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
K993313 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 50d
Cleared Nov 23, 1999
NIL, SURGEON'S GLOVE - POWDER FREE
K993349 · KGO
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 49d
Cleared Nov 23, 1999
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K993722 · LYY
Hartalega Sdn Bhd
General Hospital · 20d
Cleared Nov 23, 1999
CARDIASURE CARDIAC MARKERS CONTROL
K993723 · JJT
Quantimetrix Corp.
Chemistry · 20d
Cleared Nov 23, 1999
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K993725 · LYY
Hartalega Sdn Bhd
General Hospital · 20d
Cleared Nov 22, 1999
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
K992125 · KGI
Norland Medical Systems, Inc.
Radiology · 152d
Cleared Nov 22, 1999
PILLAR CHIN IMPLANT
K992239 · FWP
Pillar Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Nov 22, 1999
PILLAR MALAR IMPLANT
K992240 · LZK
Pillar Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Nov 22, 1999
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
K992242 · FZE
Pillar Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Nov 22, 1999
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · GGN
Medical Analysis Systems, Inc.
Hematology · 91d