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
129241–129264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1989
CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC
K895762 · GEA
Kolster Methods
General & Plastic Surgery · 22d
Cleared Oct 18, 1989
MANAN PROSTATIC BIOPSY NEEDLE
K895897 · FCG
Manan Medical Products, Inc.
Gastroenterology & Urology · 12d
Cleared Oct 18, 1989
PRECISION DENTAL ATTACHMENTS
K895986 · EGG
Implant Support Systems, Inc.
Dental · 90d
Cleared Oct 17, 1989
EMS 300 MUSCLE STIMULATORS
K890434 · IPF
Paranamics, Inc.
Physical Medicine · 263d
Cleared Oct 17, 1989
CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
K890875 · DPS
Ppg Industries, Inc.
Cardiovascular · 238d
Cleared Oct 17, 1989
VINYL BAG W/PUMP ADMINISTRATION SET
K893540 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 162d
Cleared Oct 17, 1989
VINYL BAG W/GRAVITY ADMINISTRATION SET
K893541 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 162d
Cleared Oct 17, 1989
HOLLISTER FEEDING TUBE ATTACHMENT DEVICE
K893888 · KNT
Hollister, Inc.
Gastroenterology & Urology · 140d
Cleared Oct 17, 1989
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K894033 · DXO
Deseret Medical, Inc.
Cardiovascular · 133d
Cleared Oct 17, 1989
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
K894494 · DXY
Biotronik, GmbH & Co.
Cardiovascular · 90d
Cleared Oct 17, 1989
WHITESIDE ORTHOLOC M.A. TIBIAL BASE
K894504 · JWH
Dow Corning Wright
Orthopedic · 90d
Cleared Oct 17, 1989
MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT
K894511 · HQC
Intl. Ophthalmic Industries Corp.
Ophthalmic · 90d
Cleared Oct 17, 1989
PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS
K894512 · HQC
Intl. Ophthalmic Industries Corp.
Ophthalmic · 90d
Cleared Oct 17, 1989
RELIANCE LIGHT CURE RETAINER ACRYLIC
K894564 · EBI
Reliance Orthodontic Products, Inc.
Dental · 88d
Cleared Oct 17, 1989
IQ LDH
K894578 · CFH
Bd Becton Dickinson Vacutainer...
Toxicology · 85d
Cleared Oct 17, 1989
CORDIS STEERABLE COATED GUIDEWIRE
K894633 · DQX
Cordis Corp.
Cardiovascular · 85d
Cleared Oct 17, 1989
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
K894645 · JTC
Dynatech Laboratories, Inc.
Chemistry · 85d
Cleared Oct 17, 1989
PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT
K894684 · DWF
Pioneering Technologies, Inc.
Cardiovascular · 84d
Cleared Oct 17, 1989
SOURCERER
K894902 · JJJ
Oakfield Instruments, Ltd.
Toxicology · 77d
Cleared Oct 17, 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS
K894934 · DKB
Hycor Biomedical, Inc.
Toxicology · 75d
Cleared Oct 17, 1989
CLINISTAT POTASSIUM REAGENT TEST
K895047 · CFM
Heraeus Kulzer, Inc.
Chemistry · 69d
Cleared Oct 17, 1989
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
K895118 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 17, 1989
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
K895119 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 17, 1989
MENTOR DUCTAL CATHETERS
K895285 · GBZ
Mentor Corp.
General & Plastic Surgery · 54d