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
126865–126888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1990
E-CLIP
K900982 · LDF
Joel Cohen & Esther R. Cohen
Cardiovascular · 48d
Cleared Apr 19, 1990
FILT-R-ALL BACTERIAL/VIRAL FILTER
K900990 · CAH
Inhalation Plastics
General Hospital · 48d
Cleared Apr 19, 1990
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 44d
Cleared Apr 19, 1990
SPS 550-IPS (INTEGRATED PATIENT STATION)
K901038 · FIL
Baxter Healthcare Corp
Gastroenterology & Urology · 44d
Cleared Apr 19, 1990
NO-STICK COMPOSITE INSTRUMENT DIP
K901050 · EBD
Pulpdent Corp.
Dental · 45d
Cleared Apr 19, 1990
MULTICONSTITUENT SERUM RANGE LINEARITY #88234
K901115 · JJY
Hichem Diagnostics
Chemistry · 41d
Cleared Apr 19, 1990
SONY VO-5800H VIDEOCASSETTE RECORDER
K901153 · JAA
Sony Medical Electronics Co.
Radiology · 37d
Cleared Apr 19, 1990
LITEBOX DIAGNOSTIC REVIEW WORKSTATION
K901158 · LLZ
Siemens Gammasonics, Inc.
Radiology · 37d
Cleared Apr 19, 1990
CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)
K901226 · CIC
Technicon Instruments Corp.
Chemistry · 36d
Cleared Apr 19, 1990
GRASP (GRIGG-RUSSEL AIR SUPPORT PILLOW)
K901375 · INW
Medical Plastics Laboratory, Inc.
Physical Medicine · 28d
Cleared Apr 19, 1990
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2
K901578 · CFT
Diagnostic Products Corp.
Chemistry · 15d
Cleared Apr 18, 1990
EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.
K891556 · ESD
Green Light Import Export Co., Inc.
Ear, Nose, Throat · 397d
Cleared Apr 18, 1990
MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM
K896862 · DSI
Del Mar Avionics
Cardiovascular · 133d
Cleared Apr 18, 1990
MODEL AUDINA ITE HEATING AID
K897024 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 120d
Cleared Apr 18, 1990
DYNATRON 360 RANGE OF MOTION TESTING DEVICE
K897178 · KQX
Dynatronics Corp.
Neurology · 112d
Cleared Apr 18, 1990
MULLER TYPE ACETABULAR CUP
K900257 · JDI
Lima Intl. Corp.
Orthopedic · 91d
Cleared Apr 18, 1990
IMX HCG (LIST #03A63)
K900327 · JHI
Abbott Laboratories
Chemistry · 85d
Cleared Apr 18, 1990
MC2P ACETABULAR COMPONENT
K900438 · JDI
Osteonics Corp.
Orthopedic · 78d
Cleared Apr 18, 1990
ALTA LAG SCREW AND COMPRESSION SCREW
K900584 · KTT
Howmedica Corp.
Orthopedic · 70d
Cleared Apr 18, 1990
TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
K900585 · LHI
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 70d
Cleared Apr 18, 1990
AIR FLOW SII
K900709 · ELC
Electro Medical Systems (Ems Sa)
Dental · 139d
Cleared Apr 18, 1990
THE CAROLINA ROCKER
K900839 · KNN
Artec Environmental Monitoring Division
Physical Medicine · 55d
Cleared Apr 18, 1990
GS-1000 GRASPING FORCEP, 5MM, INSULATED
K900947 · GEI
Solos Endoscopy, Inc.
General & Plastic Surgery · 50d
Cleared Apr 18, 1990
GS-1002 GRASPING FORCEP, 5MM WITH RATCHET
K900948 · GEN
Solos Endoscopy, Inc.
General & Plastic Surgery · 50d