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
114793–114816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1993
VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING)
K925097 · LMD
Vortech Data, Inc.
Radiology · 99d
Cleared Jan 15, 1993
SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM
K925107 · LNH
Shimadzu Medical Systems
Radiology · 98d
Cleared Jan 15, 1993
BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT
K925173 · LYA
Westmed Intl.
Ear, Nose, Throat · 93d
Cleared Jan 15, 1993
GIOTTO PATIENT BED
K925212 · IZH
Gold Coast Imaging, Inc.
Radiology · 91d
Cleared Jan 15, 1993
ENDOSHEATH
K925421 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 80d
Cleared Jan 15, 1993
AX-700LE AUTOMATIC X-RAY FILM PROCESSOR
K925569 · IXW
Alphatek Corp.
Radiology · 73d
Cleared Jan 15, 1993
CATION ADJUSTED MUELLER HINTON BROTH
K925644 · JWY
Pasco Laboratories, Inc.
Microbiology · 67d
Cleared Jan 15, 1993
EZ VIEW
K925693 · MDB
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Jan 15, 1993
DRYSLIDE(TM) INDOLE
K925747 · JTO
Difco Laboratories, Inc.
Microbiology · 63d
Cleared Jan 14, 1993
WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
K920873 · DQO
J-Lloyd Medical, Inc.
Cardiovascular · 324d
Cleared Jan 14, 1993
PRECISION MIST COMPRESSOR
K923324 · CAF
Precision Medical, Inc.
Anesthesiology · 191d
Cleared Jan 14, 1993
DYNATRON 400
K924319 · LIH
Dynatronics Corp.
Neurology · 154d
Cleared Jan 14, 1993
HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT
K924638 · GFO
International Technidyne Corp.
Hematology · 135d
Cleared Jan 14, 1993
VARIANT SICKLE CELL SHORT PROGRAM
K924813 · GKA
Bio-Rad
Hematology · 111d
Cleared Jan 14, 1993
IL TEST(TM) PRO-CHROM
K924884 · GGP
Instrumentation Laboratory CO
Hematology · 108d
Cleared Jan 14, 1993
SPECIFIC IGE EIA-TURBO ASSAY
K925425 · DHB
Hycor Biomedical, Inc.
Immunology · 79d
Cleared Jan 14, 1993
B-D LOSS OF RESISTANCE SYRINGE
K925902 · CAZ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 55d
Cleared Jan 14, 1993
ELIAS TGAB
K925922 · JZO
Elias U.S.A., Inc.
Immunology · 52d
Cleared Jan 14, 1993
ELIAS TMAB
K925923 · JZO
Elias U.S.A., Inc.
Immunology · 52d
Cleared Jan 13, 1993
DENTURE PRODUCT X
K914257 · EFT
Essential Dental Systems, Inc.
Dental · 478d
Cleared Jan 13, 1993
FLOW DIRECTED THERMODILUTION BALLOON CATHETER
K920869 · DYG
J-Lloyd Medical, Inc.
Cardiovascular · 323d
Cleared Jan 13, 1993
OMNI CYSTOSCOPE
K922320 · FAJ
Expanded Optics, Inc.
Gastroenterology & Urology · 240d
Cleared Jan 13, 1993
INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM
K922970 · MCW
Intensive Technology, Inc.
Cardiovascular · 208d
Cleared Jan 13, 1993
LC STRIP
K923358 · KGX
Genetic Laboratories Wound Care, Inc.
General & Plastic Surgery · 189d