FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94801–94824 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1997
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
K970666 · DIF
Bio-Rad
Chemistry · 14d
Cleared Mar 07, 1997
MODEL 700
K944180 · DSH
Memtec Corp.
Cardiovascular · 924d
Cleared Mar 07, 1997
SPECKTIN-LA TEST SET
K961892 · GFO
Analytical Control Systems, Inc.
Hematology · 295d
Cleared Mar 07, 1997
SHARPLAN RUBY LASER SYSTEM
K962446 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 256d
Cleared Mar 07, 1997
DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE
K962545 · KCT
Sterilization Cassette Systems, Inc.
General Hospital · 252d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
K962578 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
K962719 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
K962720 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
K962722 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
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