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
99793–99816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1996
ROTA-DAN RAPID ROTAVIRUS EIA KIT
K951208 · LIQ
Eldan Technologies, Ltd.
Microbiology · 334d
Cleared Feb 14, 1996
MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
K951846 · KWP
Alphatec Mfg., Inc.
Orthopedic · 300d
Cleared Feb 14, 1996
CHROM Z-HEPARIN, CAT. NO 5242
K952667 · KFF
Helena Laboratories
Hematology · 247d
Cleared Feb 14, 1996
LFIC OR FETTO HIP
K952776 · LWJ
Zimmer, Inc.
Orthopedic · 243d
Cleared Feb 14, 1996
CPR SUPER POCKET PACK
K953230 · CBP
Formosa-Cj Health Business Corp.
Anesthesiology · 219d
Cleared Feb 14, 1996
DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K953807 · LPL
Stephen A. Dunn, Inc.
Ophthalmic · 190d
Cleared Feb 14, 1996
SYSCON CONTROL ASSAYED & UNASSAYED
K954247 · JJY
Scantibodies Laboratory, Inc.
Chemistry · 156d
Cleared Feb 14, 1996
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
K954537 · DCN
Olympus America, Inc.
Immunology · 138d
Cleared Feb 14, 1996
AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS
K954652 · HRX
Aesculap, Inc.
Orthopedic · 127d
Cleared Feb 14, 1996
GLYCAR STAPLE STRIPS
K954665 · FTL
Glycar, Inc.
General & Plastic Surgery · 127d
Cleared Feb 14, 1996
LINK MP RECONSTRUCTION HIP
K955296 · JDI
Link America, Inc.
Orthopedic · 90d
Cleared Feb 14, 1996
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
K955349 · DXZ
Meadox Medicals, Div. Boston...
Cardiovascular · 85d
Cleared Feb 14, 1996
CLP BONNET
K955528 · DZB
Clp Products
Dental · 72d
Cleared Feb 14, 1996
LORENZ MANDIBULAR DISTRACTOR
K955640 · MQN
Biomet, Inc.
Dental · 64d
Cleared Feb 14, 1996
LACTOSORB TRAUMA PLATING SYSTEM
K955729 · HRS
Poly-Medics,Inc.
Orthopedic · 58d
Cleared Feb 14, 1996
IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM
K955793 · CHL
Instrumentation Laboratory CO
Chemistry · 54d
Cleared Feb 14, 1996
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
K955868 · MMI
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Feb 14, 1996
BOSWORTH IMPRESSION MATERIAL I
K960063 · ELW
Harry J. Bosworth Co.
Dental · 40d
Cleared Feb 14, 1996
IMMILITE TOTAL IGE
K960067 · JHR
Diagnostic Products Corp.
Immunology · 40d
Cleared Feb 14, 1996
DG 88
K960226 · EJT
Degussa Corp.
Dental · 28d
Cleared Feb 13, 1996
RESPIEVENTS
K942771 · DQK
Non-Invasive Monitoring Systems, Inc.
Cardiovascular · 610d
Cleared Feb 13, 1996
RESPITRACE PT
K942852 · DQK
Non-Invasive Monitoring Systems, Inc.
Cardiovascular · 610d
Cleared Feb 13, 1996
RIA LATEX CONDOM
K943880 · HIS
Mbf Personal Care Sdn. Bhd.
Obstetrics & Gynecology · 553d
Cleared Feb 13, 1996
AIA-PACK CPR ASSAY
K951848 · JKD
Tosoh Medics, Inc.
Chemistry · 298d