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
84769–84792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1999
URINE DRUG SCREENING CONTROL
K992395 · DIF
Seracare Technology
Toxicology · 38d
Cleared Aug 26, 1999
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
K992397 · JHI
Cenogenics Corp.
Chemistry · 38d
Cleared Aug 26, 1999
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY...
K992589 · LPL
Opti-Centre Laboratories
Ophthalmic · 24d
Cleared Aug 25, 1999
BIOSHIELD EXPRESS STERILIZATION WRAP
K983719 · FRG
Allegiance Healthcare Corp.
General Hospital · 308d
Cleared Aug 25, 1999
MED-RX EXTENSION SETS
K990777 · FPA
Benlan, Inc.
General Hospital · 169d
Cleared Aug 25, 1999
REDI-TEST PCP
K991698 · LCM
Redwood Biotech, Inc.
Toxicology · 99d
Cleared Aug 25, 1999
N-395 PULSE OXIMETER, MODEL N-395
K991823 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 89d
Cleared Aug 25, 1999
MINIJECT
K991888 · EJI
Spartan Ultrasonics, Inc.
Dental · 84d
Cleared Aug 25, 1999
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
K992062 · LZA
Safeskin Corp.
General Hospital · 68d
Cleared Aug 25, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
K992165 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 58d
Cleared Aug 25, 1999
POST CEMENT HI-X
K992248 · EBF
Bisco, Inc.
Dental · 50d
Cleared Aug 25, 1999
FLEXIFLO ENTERAL FEEDING TUBE
K992494 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Aug 25, 1999
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K992496 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 30d
Cleared Aug 25, 1999
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K992497 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 30d
Cleared Aug 24, 1999
NEPTUNE WASTE MANAGEMENT SYSTEM
K990037 · FYD
American Immuno Tech
General Hospital · 230d
Cleared Aug 24, 1999
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
K991942 · MLE
Cogent Diagnotics , Ltd.
Immunology · 76d
Cleared Aug 24, 1999
TRIP TONOMETRY CATHETER, 8F
K992181 · KNT
Datex-Ohmeda, Inc.
Gastroenterology & Urology · 57d
Cleared Aug 24, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
K992349 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 24, 1999
ROTOSNARE
K992477 · FDI
Inscope, LLC
Gastroenterology & Urology · 29d
Cleared Aug 24, 1999
ATC OPTION FOR EVITA 2 DURA AND EVITA 4
K992608 · CBK
Drager, Inc.
Anesthesiology · 20d
Cleared Aug 24, 1999
ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM
K992663 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Aug 24, 1999
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K992672 · FRN
Belmont Instrument Corp.
General Hospital · 14d
Cleared Aug 23, 1999
AEQUALIS SHOULDER PROSTHESIS
K980244 · KWS
Tornier
Orthopedic · 577d
Cleared Aug 23, 1999
K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
K991007 · MKJ
Katecho, Inc.
Cardiovascular · 150d