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
129265–129288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1989
MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER
K895313 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 49d
Cleared Oct 17, 1989
ANTI-RNP AND ANTI-SM ANTIBODY TEST
K895338 · LKO
Immco Diagnostics, Inc.
Immunology · 47d
Cleared Oct 17, 1989
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
K895380 · CFT
Serono-Baker Diagnostics, Inc.
Chemistry · 48d
Cleared Oct 17, 1989
BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA
K895496 · JZG
Incstar Corp.
Chemistry · 69d
Cleared Oct 17, 1989
MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM
K895643 · FDC
Orthoconcept, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 17, 1989
DIAMOND BLADE SURGICAL KNIVES
K895752 · GDM
Magnum Diamond, Inc.
General & Plastic Surgery · 21d
Cleared Oct 17, 1989
TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
K895808 · DCF
Technicon Instruments Corp.
Immunology · 15d
Cleared Oct 17, 1989
LAN.0800Q/2800Q
K895872 · DBF
Amersham Corp.
Immunology · 13d
Cleared Oct 16, 1989
LIKON
K881777 · IPF
Northwood Intl., Corp.
Physical Medicine · 538d
Cleared Oct 16, 1989
AGAR 4000 NEUROMUSCULAR STIMULATOR
K882387 · IPF
Solcoor, Inc.
Physical Medicine · 493d
Cleared Oct 16, 1989
UNI-STICK PLASTIC LIGATURES
K891331 · EJF
American Orthodontics
Dental · 220d
Cleared Oct 16, 1989
STERILE LATEX SURGEON'S GLOVES
K891404 · KGO
Shinheng Corp.
General Hospital · 216d
Cleared Oct 16, 1989
COPOLYESTER FILM DRESSING
K893647 · KGN
Tri-State Hospital Supply Corp.
General & Plastic Surgery · 154d
Cleared Oct 16, 1989
DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST
K893753 · LHK
Bd Becton Dickinson Vacutainer...
Microbiology · 150d
Cleared Oct 16, 1989
TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN
K894261 · GMN
Microbix Biosystems, Inc.
Microbiology · 117d
Cleared Oct 16, 1989
RUBELLA ANTIGEN AND CONTROL ANTIGEN
K894262 · GON
Microbix Biosystems, Inc.
Microbiology · 117d
Cleared Oct 16, 1989
IMMUNODOT RUBELLA TEST
K894546 · LFX
General Biometrics, Inc.
Microbiology · 87d
Cleared Oct 16, 1989
CLP CK/LD ISOENZYME CONTROL
K894554 · JJT
Creative Laboratory Products, Inc.
Chemistry · 88d
Cleared Oct 16, 1989
RESPIRATORY SYNCYTIAL VIRUS
K894623 · LKT
Bion Ent., Ltd.
Microbiology · 88d
Cleared Oct 16, 1989
MUMPS VIRUS
K894624 · GRA
Bion Ent., Ltd.
Microbiology · 88d
Cleared Oct 16, 1989
EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN
K894626 · LLM
Bion Ent., Ltd.
Microbiology · 88d
Cleared Oct 16, 1989
IMMUNO/ASO
K894780 · GTQ
Immunostics Co., Inc.
Microbiology · 81d
Cleared Oct 16, 1989
UNSCENTED MENSTRUAL TAMPON
K894846 · HEB
Personal Products Co.
Obstetrics & Gynecology · 77d
Cleared Oct 16, 1989
MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK
K894914 · JGS
I-Stat Corp.
Chemistry · 75d