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
86017–86040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1999
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON...
K974236 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 519d
Cleared Apr 15, 1999
BLEASE 6200 ANAESTHESIA VENTILATOR
K982132 · CBK
Blease Medical Equipment , Ltd.
Anesthesiology · 302d
Cleared Apr 15, 1999
STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR...
K983341 · JAQ
Nucletron Corp.
Radiology · 204d
Cleared Apr 15, 1999
QUANTA LITE LYME IGG ELISA
K984222 · LSR
Inova Diagnostics, Inc.
Microbiology · 141d
Cleared Apr 15, 1999
QUANTA LITE LYME IGM ELISA
K984234 · LSR
Inova Diagnostics, Inc.
Microbiology · 141d
Cleared Apr 15, 1999
NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
K984504 · LOS
Nihon Kohden America, Inc.
Cardiovascular · 118d
Cleared Apr 15, 1999
ALTHIN MEDICAL AB ALTRACART II
K990010 · KPO
Althin Medical AB
Gastroenterology & Urology · 101d
Cleared Apr 15, 1999
OPART
K990260 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Apr 15, 1999
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
K990399 · DKZ
Roche Diagnostics Corp.
Toxicology · 65d
Cleared Apr 15, 1999
ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
K990409 · DMY
Roche Diagnostics Corp.
Toxicology · 65d
Cleared Apr 15, 1999
VIEW COM
K990759 · LLZ
Electromed Intl., Ltd.
Radiology · 38d
Cleared Apr 15, 1999
STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH...
K990919 · LLZ
Visualization Technology, Inc.
Radiology · 28d
Cleared Apr 15, 1999
ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
K991018 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3,...
K991076 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8,...
K991078 · DKE
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
K991079 · JXM
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN MTD, BIOSIGN MTD
K991080 · DJR
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA...
K991082 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
K991084 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 14, 1999
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851
K982134 · KDI
Dynamic Technology Corp.
Gastroenterology & Urology · 301d
Cleared Apr 14, 1999
MEGA 4
K982144 · INI
Mega Motion, Inc.
Physical Medicine · 301d
Cleared Apr 14, 1999
MEGA 3
K982145 · INI
Mega Motion, Inc.
Physical Medicine · 301d
Cleared Apr 14, 1999
NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
K984213 · MDA
Capital Marketing Technologies, Inc.
General & Plastic Surgery · 141d
Cleared Apr 14, 1999
DUMEX IODOFORM PACKING STRIP
K990332 · FRO
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 70d