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
159937–159960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1982
EZ STAND MOBILE STOOL
K821634 · IMM
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
SOFT ULNAR DEVIATION SPLINTS
K821635 · ILH
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
ATTACH-A-PAK
K821636 · IME
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
WIRE-FOAM MP FLEXION SPRING
K821637 · ILH
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
HYGIENE ADAPTORS
K821638 · ILS
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
ANKLE FOOT ORTHOSIS
K821639 · ITW
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
ORTHOTIC FABRICATION ACCESSORIES
K821640 · IQI
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
OBTHOSES
K821641 · IQI
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
WHEEL CHAIR ACCESSORIES
K821642 · KNO
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
EATING UTENSILS
K821643 · ILC
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
VACUUM WAND AND UNI-READER
K821644 · ILP
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
BACK SKPPORTS
K821645 · IPT
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
TINY FLEX-GLASS, SET OF 4
K821646 · IKW
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
FOAM WEDGES
K821647
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
STATIONARY SPECIAL PURPOSE PODIATRY X-RAY UNIT
K827470
Franklin X-Ray Corp.
Radiology · 29d
Cleared Jun 11, 1982
MODEL ML-820 CARBON DIOXIDE LASER SYSTEM FOR SURGERY
K827506
Merrimack Laboratories
Radiology · 38d
Cleared Jun 10, 1982
THE ORIGINAL LEINBACH PLATFORM TOTAL HIP
K820755 · KWL
Allo Pro Corp.
Orthopedic · 83d
Cleared Jun 10, 1982
SYPHILIS BIO-ENZABEAD KIT
K820934 · LIP
Biometics Laboratory Products
Microbiology · 69d
Cleared Jun 10, 1982
DENTRON-EXACT - TRAY
K820997 · EBH
Dentron, Inc.
Dental · 62d
Cleared Jun 10, 1982
DENTRON-DIRECT-TRAY
K820998 · EBH
Dentron, Inc.
Dental · 62d
Cleared Jun 10, 1982
MODEL AS6M INFUSION PUMP
K821069 · FRN
Baxter Healthcare Corp
General Hospital · 55d
Cleared Jun 10, 1982
SPHYGURITE
K821095 · DXQ
Associated Medical Devices, Inc.
Cardiovascular · 52d
Cleared Jun 10, 1982
SELECT BIPOLAR COAGULATION FORCEPS
K821263 · GEI
ZEISS
General & Plastic Surgery · 38d
Cleared Jun 10, 1982
HYPODERMIC NEEDLES & SYRINGES
K821348 · GAA
Medi-Tech, Inc.
General & Plastic Surgery · 36d