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
106729–106752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1994
MONOJECT TRAY SIZE SHARPS CONTAINER
K943496 · FMI
Sherwood Medical Co.
General Hospital · 41d
Cleared Aug 29, 1994
SOFTWEAR PORCELAIN SYSTEM
K943582 · EIH
Dentsply Intl.
Dental · 38d
Cleared Aug 29, 1994
SUNGLASSES
K943677 · HQY
Jenn Wei Glass Company, Ltd.
Ophthalmic · 34d
Cleared Aug 29, 1994
ARGESOL #720
K943779 · EJT
Argen Precious Metals, Inc.
Dental · 26d
Cleared Aug 29, 1994
MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS
K943818 · GEI
R-Med, Inc.
General & Plastic Surgery · 24d
Cleared Aug 29, 1994
SUNGLASSES
K943912 · HQY
Kason Enterprises Limited
Ophthalmic · 18d
Cleared Aug 26, 1994
AQUACISER II
K925193 · ILJ
Aquaciser, Inc.
Physical Medicine · 680d
Cleared Aug 26, 1994
EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE)
K926218 · HIR
Sandhill Scientific, Inc.
Gastroenterology & Urology · 624d
Cleared Aug 26, 1994
GAMBRO LUNDIA PRO 200 DIALYZER
K933680 · FJG
Cobe Renal Care, Inc.
Gastroenterology & Urology · 393d
Cleared Aug 26, 1994
HAND-HELD IRRIGATION PUMP
K933757 · BTA
Ximed Medical Systems
General & Plastic Surgery · 408d
Cleared Aug 26, 1994
STREP-A-CHEK
K934129 · JTO
E-Y Laboratories, Inc.
Microbiology · 379d
Cleared Aug 26, 1994
SLT PRISM/REFRACTING PROBE
K934208 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 361d
Cleared Aug 26, 1994
MODULAR FORCEP AND SCISSOR SYSTEM
K935270 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 297d
Cleared Aug 26, 1994
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE
K936271 · KIR
Diagnostic Hybrids, Inc.
Pathology · 239d
Cleared Aug 26, 1994
STREP-A-CHEK(TM) REAGENT STRIPS
K940020 · JTO
E-Y Laboratories, Inc.
Microbiology · 235d
Cleared Aug 26, 1994
EY-20 REAGENT TUBES
K940124 · JTO
E-Y Laboratories, Inc.
Microbiology · 228d
Cleared Aug 26, 1994
HYPERFLEX FLEXIBLE GUIDEWIRES
K941711 · LXH
Linvatec Corp.
Orthopedic · 142d
Cleared Aug 26, 1994
ROCHE REAGENT FOR CREATININE
K941837 · CGX
Roche Diagnostic Systems, Inc.
Chemistry · 135d
Cleared Aug 26, 1994
APEX DISPOSABLE INSTRUMENTS
K941907 · MDM
Apex Ent., Inc.
General & Plastic Surgery · 129d
Cleared Aug 26, 1994
ARGON CURING LASER
K942204 · GEX
Bio-Laser Technology, Inc.
General & Plastic Surgery · 113d
Cleared Aug 26, 1994
CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET
K942284 · JJX
Creative Laboratory Products, Inc.
Chemistry · 107d
Cleared Aug 26, 1994
STAR I WORKSTATION
K942290 · JQW
Standard Engineering
Chemistry · 107d
Cleared Aug 26, 1994
AURAFLEX SYSTEMS
K942443 · JJE
Organon Teknika Corp.
Chemistry · 95d
Cleared Aug 26, 1994
MDT UROLOGY TABLE
K942485 · MMZ
Mdt Corp., Inc.
Gastroenterology & Urology · 93d