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
132601–132624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1989
GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES
K890538 · LYY
Boston Medical Corp.
General Hospital · 35d
Cleared Mar 10, 1989
HI CHEM WASH CONCENTRATE REAGENT #88805
K890578 · JQW
Hichem Diagnostics
Chemistry · 32d
Cleared Mar 10, 1989
TRACHEOSTOMY CARE AND CLEANING KITS
K890726 · LRO
Cypress Medical Products, Ltd.
General & Plastic Surgery · 25d
Cleared Mar 10, 1989
NON-STERILE, BULK GAUZE SPONGES
K890727 · EFQ
Cypress Medical Products, Ltd.
General & Plastic Surgery · 25d
Cleared Mar 10, 1989
DRY TIPS
K890734 · KHR
Microcopy, Div. Neo-Flo, Inc.
Dental · 25d
Cleared Mar 10, 1989
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
K890785 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 23d
Cleared Mar 10, 1989
ABUSCREEN FP FOR AMPHETAMINE
K890886 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Mar 09, 1989
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
K881970 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 302d
Cleared Mar 09, 1989
ARGIS PULMONARY FUNCTION TESTING SYSTEM
K883732 · BZC
Advanced Signal Processing, Inc.
Anesthesiology · 190d
Cleared Mar 09, 1989
NR2000 CARDIAC MONITOR
K883903 · DPS
Nirad , Ltd.
Cardiovascular · 175d
Cleared Mar 09, 1989
MODEL 702 ECG/RESPIRATION/TEMPERATURE
K884455 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 136d
Cleared Mar 09, 1989
ELECTRODE GEL
K884504 · DPS
Herbert Stanley Co.
Cardiovascular · 135d
Cleared Mar 09, 1989
OPTIFIELD I AND II AUTOMATED PERIMETERS
K884867 · HPT
Optimed, Inc.
Ophthalmic · 108d
Cleared Mar 09, 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · DSF
Mennen Medical, Inc.
Cardiovascular · 106d
Cleared Mar 09, 1989
RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM
K884917 · IZH
Amg Medical Equipments, Inc.
Radiology · 101d
Cleared Mar 09, 1989
M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55
K884983 · DRX
S & W Medico Teknik
Cardiovascular · 100d
Cleared Mar 09, 1989
M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40
K884984 · DRX
S & W Medico Teknik
Cardiovascular · 100d
Cleared Mar 09, 1989
MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150
K885135 · IZH
Bennett X-Ray Corp.
Radiology · 84d
Cleared Mar 09, 1989
ENDOSCOPIC LIGHT SOURCE
K885183 · HRX
Technology For Imaging, Inc.
Orthopedic · 86d
Cleared Mar 09, 1989
ROCKET ENDOCERVICAL BRUSH
K885274 · HHT
A & A Medical, Inc.
Obstetrics & Gynecology · 77d
Cleared Mar 09, 1989
CALIUS-ISABEL CANOVAS SUNGLASSES
K890081 · HQY
Roseburg SA
Ophthalmic · 58d
Cleared Mar 09, 1989
TARGET(TM) QUANTITATIVE HCG
K890131 · JHI
V-Tech, Inc.
Chemistry · 56d
Cleared Mar 09, 1989
TOTAL PROTEIN REAGENT
K890278 · CEK
Sigma Chemical Co.
Chemistry · 50d
Cleared Mar 09, 1989
TRIGLYCERIDES - GPO REAGENT
K890337 · CDT
Alpkem Corp.
Chemistry · 45d