FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
117841–117864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1992
IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE
K921378 · FRN
Imed Corp.
General Hospital · 78d
Cleared Jun 09, 1992
ORS-100
K921568 · JRM
Mnlase, Inc.
Chemistry · 68d
Cleared Jun 09, 1992
ORS-200
K921569 · JRM
Mnlase, Inc.
Chemistry · 68d
Cleared Jun 09, 1992
ORS-300
K921570 · JRM
Mnlase, Inc.
Chemistry · 68d
Cleared Jun 09, 1992
AVK CONTROL I & II
K921665 · GGC
American Bioproducts Co.
Hematology · 63d
Cleared Jun 09, 1992
CIBA CORNING ACS FOLATE IMMUNOASSAY
K921678 · JIX
Ciba Corning Diagnostics Corp.
Chemistry · 62d
Cleared Jun 09, 1992
PTT-LA TEST KIT
K921684 · GGW
American Bioproducts Co.
Hematology · 62d
Cleared Jun 09, 1992
DURAFILL BOND
K921701 · KLE
Heraeus Kulzer, Inc.
Dental · 62d
Cleared Jun 09, 1992
IMMULITE(R) FSH
K921704 · CGJ
Cirrus Diagnostics, Inc.
Chemistry · 60d
Cleared Jun 09, 1992
DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED
K921728 · LYX
Chiron Intraoptics
Ophthalmic · 76d
Cleared Jun 09, 1992
OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED
K921729 · LYX
Chiron Intraoptics
Ophthalmic · 76d
Cleared Jun 09, 1992
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K921763 · JHY
Hybritech, Inc.
Chemistry · 56d
Cleared Jun 09, 1992
QUICKANCHOR, MODIFICATION
K921873 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 62d
Cleared Jun 09, 1992
UNICALIBRATOR KIT
K922021 · GIZ
American Bioproducts Co.
Hematology · 40d
Cleared Jun 09, 1992
VALTRAC(R) INTRODUCER FORCEP
K922348 · HJE
American Cyanamid Co.
General & Plastic Surgery · 21d
Cleared Jun 08, 1992
THERMAL PROBE COVER
K915831 · FMT
Vermont Medical, Inc.
General Hospital · 161d
Cleared Jun 08, 1992
OMNIFLEX M-HA HIP STEM SERIES
K920193 · KWL
Stryker Corp.
Orthopedic · 145d
Cleared Jun 08, 1992
OMNIFIT M-HA HIP STEM SERIES
K920231 · KWL
Stryker Corp.
Orthopedic · 143d
Cleared Jun 08, 1992
CKS OSCILLATING SAW BLADE
K921131 · HWE
Techmedica, Inc.
Orthopedic · 90d
Cleared Jun 08, 1992
SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40
K921146 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 90d
Cleared Jun 05, 1992
R-GROUP INTL. ONE WALL PUNCTURE NEEDLE
K913267 · DRC
R-Group Intl.
Cardiovascular · 318d
Cleared Jun 05, 1992
SETUP COMPUTER WITH SOFTWARE V-1261,62 AND 63
K914698 · IYE
K.S., Inc.
Radiology · 231d
Cleared Jun 05, 1992
PAPILLION PROCTOSCOPE
K914784 · KQA
Oldelft Corp. of America
Radiology · 226d
Cleared Jun 05, 1992
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS.
K920062 · GEX
Candela Laser Corp.
General & Plastic Surgery · 150d