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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
98761–98784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 29, 1996
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II
K952126 · GGP
Aalto Scientific, Ltd.
Hematology · 297d
Cleared Feb 29, 1996
SPEEDBAND
K952262 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 290d
Cleared Feb 29, 1996
ACCUSTRESS EXERCISE TESTING SYSTEM
K953127 · DQK
Hewlett-Packard Co.
Cardiovascular · 239d
Cleared Feb 29, 1996
SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE
K953349 · CBP
Spiracle Technology
Anesthesiology · 227d
Cleared Feb 29, 1996
MANUAL PULMONARY RESUSICITATOR
K953546 · BTM
Medical Marketing Concepts
Anesthesiology · 216d
Cleared Feb 29, 1996
CODMAN FIDUCIAL MARKER SYSTEM
K953568 · HAW
Codman & Shurtleff, Inc.
Neurology · 213d
Cleared Feb 29, 1996
OVULATION CALCULATOR/CONCEPTION CALCULATOR
K954183 · MPT
Hector Vides
Obstetrics & Gynecology · 176d
Cleared Feb 29, 1996
QUANTA LITE SSDNA
K954380 · LJM
Inova Diagnostics, Inc.
Immunology · 163d
Cleared Feb 29, 1996
FLOW-COUNT COULTER FLUOROSPHERES
K954688 · GKZ
Coulter Corp.
Hematology · 141d
Cleared Feb 29, 1996
ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
K954718 · HEE
Ellman Intl., Inc.
Obstetrics & Gynecology · 139d
Cleared Feb 29, 1996
ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT
K955266 · JHI
Boehringer Mannheim Italia Spa
Chemistry · 106d
Cleared Feb 29, 1996
PHOENIX DIALYSATE METER
K955298 · FIZ
Automata Medical Instrumentation, Inc.
Gastroenterology & Urology · 101d
Cleared Feb 29, 1996
SERUM BICARBONATE/CARBON DIOXIDE
K955302 · KHS
Data Medical Associates, Inc.
Chemistry · 101d
Cleared Feb 29, 1996
NEUROVIEW COAXIAL BIPOLAR ELECTRODE
K955351 · GWG
Neuro Navigational Corp.
Neurology · 100d
Cleared Feb 29, 1996
BIO-ANCHOR
K955486 · MAI
Linvatec Corp.
Orthopedic · 90d
Cleared Feb 29, 1996
GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES
K955558 · FBK
Medi-Globe Corp.
Gastroenterology & Urology · 85d
Cleared Feb 29, 1996
BIOCLOT PROTEIN S
K955738 · GGP
Medical Diagnostic Technologies, Inc.
Hematology · 76d
Cleared Feb 29, 1996
IRON CALIBRATOR & CALIBRATION VERIFICATION SET
K955796 · JJX
Data Medical Associates, Inc.
Chemistry · 69d
Cleared Feb 29, 1996
GIBSON ID-M. CAT.
K955826 · JTO
Gibson Laboratories, Inc.
Microbiology · 65d
Cleared Feb 29, 1996
CBC-CAL PLUS HEMATOLOGY CALIBRATOR
K955925 · KRX
R&D Systems, Inc.
Hematology · 69d
Cleared Feb 29, 1996
DSL ACTIVE PROLACTIN IRMA
K960060 · CFT
Diagnostic Systems Laboratories, Inc.
Chemistry · 56d
Cleared Feb 29, 1996
NHMC FOLEY CATHETERIZATION TRAY
K960566 · FCM
National Healthcare Mfg. Corp.
Gastroenterology & Urology · 20d
Cleared Feb 28, 1996
ART-ASSIST MODEL AA-1000
K942530 · JOW
Aci Medical, Inc.
Cardiovascular · 642d
Cleared Feb 28, 1996
PUMP/BLOOD CHEMISTRY MONITOR
K951739 · LZF
Via Medical Corp.
General Hospital · 320d