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
98521–98544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1996
FLEXON TEMPORARY CARDIAC PACER LEAD
K955722 · LDF
Davis & Geck, Inc.
Cardiovascular · 88d
Cleared Mar 15, 1996
VARIS PORTALVISION
K955774 · IYE
Varian Assoc., Inc.
Radiology · 85d
Cleared Mar 15, 1996
NIOMED SURGICAL CAPS
K955833 · FYF
Amerasia Corp.
General & Plastic Surgery · 80d
Cleared Mar 15, 1996
J.B. S. C1-C2 CLAMP
K955864 · KWP
J.B.S., S.A.
Orthopedic · 79d
Cleared Mar 15, 1996
BLADDERSCAN BVI 5000
K955942 · IYO
Diagnostic Ultrasound Corp.
Radiology · 80d
Cleared Mar 15, 1996
KIS MT5
K960112 · DZE
The Implant Center of the Palm Beaches
Dental · 64d
Cleared Mar 15, 1996
ALPHA-DENT COMPOSITE SURFACE SEALANT
K960165 · EBF
Wallace A. Erickson & Co.
Dental · 59d
Cleared Mar 15, 1996
PROLEX MESH
K960219 · FTL
Advanced Surgical Innovations, Inc.
General & Plastic Surgery · 59d
Cleared Mar 15, 1996
DENTALOGIC
K960270 · EJI
Protecs Syringes International Corp.
Dental · 57d
Cleared Mar 15, 1996
LAURUS NEEDLE CORE BIOPSY SYSTEM
K960317 · FCG
Laurus Medical Corp.
Gastroenterology & Urology · 52d
Cleared Mar 15, 1996
CONSENSUS APEX DOME HOLE PLUG
K960340 · JDI
U.S. Medical Products, Inc.
Orthopedic · 51d
Cleared Mar 15, 1996
IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013
K960480 · ELL
Vident
Dental · 42d
Cleared Mar 15, 1996
DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE
K960547 · ELW
Espe GmbH & Co. Kg.
Dental · 36d
Cleared Mar 15, 1996
MAHLER ABDOMINAL WALL ELEVATOR
K960878 · GCJ
Cook Urological, Inc.
General & Plastic Surgery · 11d
Cleared Mar 14, 1996
DIGITAL CONDUCTANCE METER
K924313 · HCC
The Jayms Co.
Neurology · 1296d
Cleared Mar 14, 1996
VARICELISA, MODIFICATION
K943843 · LFY
Biowhittaker Molecular Applications,...
Microbiology · 595d
Cleared Mar 14, 1996
ECLIPSE PROBE COVER
K953673 · IYO
Parker Laboratories, Inc.
Radiology · 220d
Cleared Mar 14, 1996
6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE
K953773 · IYO
Medison America, Inc.
Radiology · 213d
Cleared Mar 14, 1996
FEMRX OPERASTAR SYSTEM
K954648 · HIH
Gynecare Innovation Center
Obstetrics & Gynecology · 156d
Cleared Mar 14, 1996
DOYLE EXTRACTOR
K955748 · FMI
Safetech Intl., Inc.
General Hospital · 90d
Cleared Mar 14, 1996
G.E. STERILE AMNIOCENTESIS TRAY
K960203 · HIO
GE Medical Systems
Obstetrics & Gynecology · 58d
Cleared Mar 14, 1996
DETECT CYTOLOGY BRUSH II
K960469 · HHT
Cook Urological, Inc.
Obstetrics & Gynecology · 42d
Cleared Mar 13, 1996
FREEMAN/SAMUELSON TOTAL KNEE SYSTEM
K943025 · JWH
Biomet, Inc.
Orthopedic · 625d
Cleared Mar 13, 1996
CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1
K951193 · DXN
Tycos Instruments, Inc.
Cardiovascular · 363d