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
131473–131496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1989
EXTERNAL FEEDING SET FOR PUMP USE
K890396 · FPD
Multi-Med, Inc.
Gastroenterology & Urology · 119d
Cleared May 23, 1989
CLOSED SYSTEM URINARY DRAINAGE BAG
K890465 · EYZ
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 112d
Cleared May 23, 1989
PERIPHERAL ATHERECTOMY SYSTEM
K890515 · DWX
Intensive Technology, Inc.
Cardiovascular · 111d
Cleared May 23, 1989
BEAM TECH WOUND DRESSING*
K890603 · NAD
Beam Tech , Ltd.
General & Plastic Surgery · 106d
Cleared May 23, 1989
MCINTYRE SURGICAL GONIOLENS
K890977 · HKS
Ocular Instruments, Inc.
Ophthalmic · 85d
Cleared May 23, 1989
LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC
K891130 · GEX
Lifestream Int'L, Inc.
General & Plastic Surgery · 81d
Cleared May 23, 1989
TECNOL SECURE-ALL TUBE HOLDER
K891178 · EYZ
Tecnol New Jersey Wound Care, Inc.
Gastroenterology & Urology · 78d
Cleared May 23, 1989
SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
K891290 · HES
Cook Ob/Gyn
Obstetrics & Gynecology · 74d
Cleared May 23, 1989
WILLIAMS BELT & BOOT
K891387 · JEB
Arthro-Medic, Inc.
General & Plastic Surgery · 70d
Cleared May 23, 1989
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
K891601 · HQE
Mira, Inc.
Ophthalmic · 64d
Cleared May 23, 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
K892006 · DRT
Healthdyne, Inc.
Cardiovascular · 56d
Cleared May 23, 1989
GRAND GUARD SURGICAL GLOVES
K892061 · KGO
Galaxy Intl., Inc.
General Hospital · 54d
Cleared May 23, 1989
BIPOLAR HIP SYSTEM
K892398 · KXA
Orthomet, Inc.
Orthopedic · 46d
Cleared May 23, 1989
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE
K893013 · GEX
Luxar Medical Laser Instruments
General & Plastic Surgery · 29d
Cleared May 22, 1989
ND1100 BONE DENSITY SCANNER
K881383 · KGI
Nuclear Data, Inc.
Radiology · 416d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVE
K890592 · LYY
Alfaseal Sdn. Bhd.
General Hospital · 105d
Cleared May 22, 1989
COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
K890618 · CEK
Kenlor Industries, Inc.
Chemistry · 104d
Cleared May 22, 1989
DUPONT DISTAL HUMERAL NAIL
K890939 · HRS
Howmedica Corp.
Orthopedic · 87d
Cleared May 22, 1989
OXITRON OXYGEN ANALYZER
K890958 · CCL
Oxitron Medical Products
Anesthesiology · 84d
Cleared May 22, 1989
COAG-1 APTT TEST CARD
K891015 · GFO
Cardiovascular Diagnostic Services
Hematology · 83d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891177 · LYY
Garrett-Hewitt Intl., Inc.
General Hospital · 77d
Cleared May 22, 1989
ROCHE(R) CARDIOSCREEN-CK
K891462 · CGS
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared May 22, 1989
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891468 · CIT
Trace Scientific , Ltd.
Chemistry · 68d
Cleared May 22, 1989
YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER
K891480 · CGA
Yellow Springs Instrument Co., Inc.
Chemistry · 66d