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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
155617–155640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1983
EGS MODEL 100-2
K832370
Electro-Med Health Industries, Inc.
Dental · 60d
Cleared Sep 15, 1983
VENTILATOR #1
K830488 · CBK
Ohio Medical Products
Anesthesiology · 212d
Cleared Sep 15, 1983
MICRO-STRUCTURED SURFACE HIP PROSTHESIS
K831708
Osteonics Corp.
Orthopedic · 81d
Cleared Sep 15, 1983
INFUSE-A-PORT
K832788 · LJT
Infusaid Corp.
General Hospital · 27d
Cleared Sep 12, 1983
ACCU-RYNGE PUMP SP-250
K830389 · FRN
Delta Medical Industries
General Hospital · 214d
Cleared Sep 12, 1983
AUTOMATED 8400 BLOOD CELL SEPARATOR
K831004 · LKN
Intl. Business Machines
Gastroenterology & Urology · 167d
Cleared Sep 12, 1983
DENTALON
K831077 · EBG
Kulzer, Inc.
Dental · 161d
Cleared Sep 12, 1983
DENTACOLOR LIGHT CURING CROWN & BRIDGE
K831215 · EBF
Kulzer, Inc.
Dental · 151d
Cleared Sep 12, 1983
LARYNGOSCOPE ATTACHMENT PH2000
K831255 · EQN
Eder Instrument Co, Inc.
Ear, Nose, Throat · 147d
Cleared Sep 12, 1983
BOMED BIOCON
K831421 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 132d
Cleared Sep 12, 1983
BIOFLOW
K831422 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 132d
Cleared Sep 12, 1983
AIR SHIELDS AS-100 MONIORING SYS-AS105
K831430 · DRT
Narco Scientific
Cardiovascular · 132d
Cleared Sep 12, 1983
SINGLE USE SYRINGE #103 PERSONAL MEDIC
K831444 · FRN
Pacesetter Systems
General Hospital · 130d
Cleared Sep 12, 1983
INFUSION SETS #'S 124 & 142 PERSONAL
K831445 · FPA
Pacesetter Systems
General Hospital · 130d
Cleared Sep 12, 1983
DOWNS ADJUSTABLE FLOW GENERATOR
K831503 · BYE
Vital Signs, Inc.
Anesthesiology · 124d
Cleared Sep 12, 1983
BIO-TEK PERCENT OXYGEN MONITOR 74222
K831522 · CCL
Bio-Tek Instruments, Inc.
Anesthesiology · 123d
Cleared Sep 12, 1983
PUMPETTE AS8P-INFUSION PUMP
K831534 · FRN
Travenol Laboratories, S.A.
General Hospital · 123d
Cleared Sep 12, 1983
ANESTHESIA/RESPIRATORY DISCONNECT -
K831650 · BZQ
Plasmedics, Inc.
Anesthesiology · 112d
Cleared Sep 12, 1983
EVOKED POTENTIAL SYSTEM 2000
K831651 · GWE
Ophthalmetric Corp.
Neurology · 112d
Cleared Sep 12, 1983
PLASTIC THUMB FORCEPS
K831664 · KDC
Medcare Products
General & Plastic Surgery · 112d
Cleared Sep 12, 1983
DISPOSABLE NEEDLE HOLDER
K831665 · KDC
Medcare Products
General & Plastic Surgery · 112d
Cleared Sep 12, 1983
FEMININE HYGIENE DEVICE
K831667 · HED
Snow Willow Co.
Obstetrics & Gynecology · 112d
Cleared Sep 12, 1983
STERILE FOLEY CATHETERS & UROLOGICAL
K831743 · KOD
Electromedics, Inc.
Gastroenterology & Urology · 104d
Cleared Sep 12, 1983
URIAS PRESSURE SPLINTS, & FIRST AID
K831764 · FZF
Svenol Andersen
General & Plastic Surgery · 103d