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
94297–94320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
K962727 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY
K962728 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
K962729 · DHR
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
K962730 · LRM
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY
K962731 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
(LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC)...
K964528 · LPL
Benz Research and Development Corp.
Ophthalmic · 115d
Cleared Mar 07, 1997
OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)
K964924 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 88d
Cleared Mar 06, 1997
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
K951632 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 699d
Cleared Mar 06, 1997
ROLLER ELECTRODE
K954488 · HIH
Olympus America, Inc.
Obstetrics & Gynecology · 526d
Cleared Mar 06, 1997
SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
K960072 · GKZ
Biochem Immunosystems (U.S.), Inc.
Hematology · 426d
Cleared Mar 06, 1997
SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE
K962327 · FMQ
Sekure Seat Corp.
General Hospital · 262d
Cleared Mar 06, 1997
CARDIOSERV P
K962547 · DRO
Marquette Electronics, Inc.
Cardiovascular · 251d
Cleared Mar 06, 1997
COROMETRICS MODEL 510 AND 511 MONITOR
K962781 · BZQ
Ge Medical Systems Information...
Anesthesiology · 232d
Cleared Mar 06, 1997
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
K963974 · DEW
Beckman Instruments, Inc.
Immunology · 155d
Cleared Mar 06, 1997
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
K964066 · LJT
C.R. Bard, Inc.
General Hospital · 147d
Cleared Mar 06, 1997
ELIAS ANA-HEP-2
K964385 · LJM
Elias U.S.A., Inc.
Immunology · 122d
Cleared Mar 06, 1997
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD...
K964609 · JBP
Array Medical, Inc.
Hematology · 108d
Cleared Mar 06, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT
K964843 · JZH
Beckman Instruments, Inc.
Immunology · 93d
Cleared Mar 06, 1997
ANATOM 2000
K964890 · JAK
Analogic Corp.
Radiology · 90d
Cleared Mar 06, 1997
THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
K964939 · BZC
Creative Biomedics, Inc.
Anesthesiology · 86d
Cleared Mar 06, 1997
SENTURA SURGICAL GLOVES
K964962 · KGO
Maxxim Medical
General Hospital · 85d
Cleared Mar 06, 1997
BIOCOR 200 HIGH PERFORMANCEOXYGENATOR
K964967 · DTZ
Minntech Corp.
Cardiovascular · 86d
Cleared Mar 06, 1997
ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH...
K964980 · KGO
Maxxim Medical
General Hospital · 83d
Cleared Mar 06, 1997
COULTER AC.T SERIES ANALYZER
K964988 · GKZ
Coulter Corp.
Hematology · 83d