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
109705–109728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1994
BACTICARD CANDIDA
K935124 · JXB
Remel Co.
Microbiology · 120d
Cleared Feb 25, 1994
SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS
K935318 · KPS
Summit Nuclear
Radiology · 113d
Cleared Feb 25, 1994
R & D BATTERIES, INC. PART NUMBER 5047
K935472 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 120d
Cleared Feb 25, 1994
DRESSING CHANGE TRAY
K935686 · LRO
Cush Medical Products
General Hospital · 88d
Cleared Feb 25, 1994
SPECTACLE FRAME
K935920 · HQY
Cadore Moda USA, Inc.
Ophthalmic · 77d
Cleared Feb 25, 1994
EVATEST STRIP
K936013 · LCX
Boehringer Mannheim Italia Spa
Chemistry · 71d
Cleared Feb 25, 1994
MANAN GENERAL PURPOSE INTRODUCER NEEDLE
K940024 · GAA
Manan Medical Products, Inc.
General & Plastic Surgery · 53d
Cleared Feb 25, 1994
MANAN BONE MARROW HARVEST NEEDLES
K940025 · GAA
Manan Medical Products, Inc.
General & Plastic Surgery · 53d
Cleared Feb 25, 1994
ALPHA-DENT
K940120 · ELW
Wallace A. Erickson & Co.
Dental · 46d
Cleared Feb 25, 1994
TABLE MAT MORTORIZED/ELECTRIC
K940131 · INQ
Med Mart, Inc.
Physical Medicine · 53d
Cleared Feb 25, 1994
INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT...
K940327 · FMW
W.L. Gore & Associates, Inc.
General Hospital · 32d
Cleared Feb 25, 1994
IODOFORM PACKAGING STRIP
K940339 · FRO
Albahealth Products
General & Plastic Surgery · 31d
Cleared Feb 25, 1994
8 X 10 NON-STICK PAD
K940344 · EFQ
Certified Safety Mfg., Inc.
General & Plastic Surgery · 31d
Cleared Feb 25, 1994
TRIANGULAR BANDAGE
K940345 · EFQ
Certified Safety Mfg., Inc.
General & Plastic Surgery · 31d
Cleared Feb 25, 1994
TRAUMA PAD 5 X 9
K940348 · EFQ
Certified Safety Mfg., Inc.
General & Plastic Surgery · 31d
Cleared Feb 25, 1994
EXTRA LARGE COMPRESS DRESSING
K940351 · EFQ
Certified Safety Mfg., Inc.
General & Plastic Surgery · 31d
Cleared Feb 25, 1994
MANAN ADAPTER FOR BARD BIOPTY SYSTEM
K940365 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 24, 1994
KVOI.V. FLUSH SYSTEM
K923224 · FRN
Baxter Healthcare Corp
General Hospital · 603d
Cleared Feb 24, 1994
KLEAR-TEMP
K926030 · FMT
Cas Medical Systems, Inc.
General Hospital · 450d
Cleared Feb 24, 1994
OVUM FORCEPS
K926528 · HCZ
Thomasville Medical Assoc.
Obstetrics & Gynecology · 421d
Cleared Feb 24, 1994
Z CLAMP SCISSORS
K926529 · KNA
Thomasville Medical Assoc.
Obstetrics & Gynecology · 421d
Cleared Feb 24, 1994
MIYA HOOK
K926530 · KNA
Thomasville Medical Assoc.
Obstetrics & Gynecology · 421d
Cleared Feb 24, 1994
NEEDLE EXTENSIONS
K926537 · KNA
Thomasville Medical Assoc.
Obstetrics & Gynecology · 421d
Cleared Feb 24, 1994
TISCHLER BIOPSY FORCEPS
K926538 · HFB
Thomasville Medical Assoc.
Obstetrics & Gynecology · 421d