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
170641–170664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1978
FORCEPS, ELECTROSURGICAL
K781109 · HIN
Kli
Obstetrics & Gynecology · 76d
Cleared Sep 14, 1978
DISSCAP
K781142 · FJI
Hospal Medical Corp.
Gastroenterology & Urology · 66d
Cleared Sep 14, 1978
HEMAC LASER HEMATOLOGY SYSTEM
K781146 · GKL
Ortho Instruments
Hematology · 66d
Cleared Sep 14, 1978
COMPUTER INTERFACE IL 814
K781173 · JQP
Instrumentation Laboratory CO
Chemistry · 63d
Cleared Sep 14, 1978
CLINAC 12/10
K781174 · IYE
Varian Assoc., Inc.
Radiology · 63d
Cleared Sep 14, 1978
CAMERAS, MULTI-IMAGE
K781214
Dunn Instruments, Inc.
Radiology · 59d
Cleared Sep 14, 1978
QUANTICEL-HRP
K781247 · JPK
Bhp Diagnostix, Inc.
Hematology · 55d
Cleared Sep 14, 1978
PREAMPLIFIER MODEL 113
K781289 · GWL
Princeton Applied Research Corp.
Neurology · 49d
Cleared Sep 14, 1978
HEMOGLOBINOMETER MODEL 720 B
K781361 · GKR
Innovative Medical Systems, Inc.
Hematology · 38d
Cleared Sep 14, 1978
STANDARDIZE TGCL & TGCH
K781376 · JTX
American Monitor Corp.
Chemistry · 36d
Cleared Sep 14, 1978
MODEL 5000, LIQUID CHROMATOGRAPHY
K781379 · KIE
Varian Assoc., Inc.
Toxicology · 34d
Cleared Sep 14, 1978
EBS 775 TONOMETER
K781386 · LCH
Equilibrated Bio Systems, Inc.
Chemistry · 34d
Cleared Sep 14, 1978
CREATININE REAGENT SET
K781396 · CGX
Nobel Scientific Industries, Inc.
Chemistry · 35d
Cleared Sep 14, 1978
EM-V
K781397 · KSG
Biological Corp. of America
Hematology · 34d
Cleared Sep 14, 1978
ORTHO LOW IONIC SOLUTION
K781435 · KSG
Ortho Diagnostics, Inc.
Hematology · 29d
Cleared Sep 14, 1978
AUTO-FIELD II OPHTHALMIC FIELD SCANNER
K781462 · HPT
Cavitron Corp.
Ophthalmic · 20d
Cleared Sep 14, 1978
RIANEN ASSAY SYSTEM, 125I KIT
K781495 · DNL
New England Nuclear
Immunology · 15d
Cleared Sep 14, 1978
XIMATRON IV
K781496 · KPQ
Siemens Elema AB
Radiology · 15d
Cleared Sep 14, 1978
MODEL 845T IMAGING/ERGOMETER TABLE
K781500 · JYZ
Quinton, Inc.
Radiology · 15d
Cleared Sep 14, 1978
HEARING AID, UNITRON MODEL 960PL
K781513 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 13d
Cleared Sep 14, 1978
EMI SIMULATOR REMOTE CONTROL CONSOLE
K781519 · KPQ
Emi Medical, Inc.
Radiology · 13d
Cleared Sep 14, 1978
OPTIPLANIMAT
K781531 · IZF
Siemens Corp.
Radiology · 8d
Cleared Sep 14, 1978
UROSKOP A AND B
K781532 · IXR
Siemens Corp.
Radiology · 8d
Cleared Sep 14, 1978
VAC-U-PAC KIDNEY CASSETTE
K781536 · JXA
E-Z-Em, Inc.
Radiology · 8d