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
105241–105264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1994
KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES
K945751 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 22d
Cleared Dec 15, 1994
OPTICAL FRAMES
K945770 · HQZ
Ramada Optics, Inc.
Ophthalmic · 43d
Cleared Dec 15, 1994
INSUFFLATOR FILTER TUBING SET
K945970 · FCX
Xylog Corp.
Gastroenterology & Urology · 7d
Cleared Dec 14, 1994
MULTILINK SHOULDER CPM UNIT
K935587 · BXB
Toronto Medical Corp.
Physical Medicine · 393d
Cleared Dec 14, 1994
TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K941171 · GKZ
Miles, Inc.
Hematology · 275d
Cleared Dec 14, 1994
DIARLEX ROTA-ADENO
K942286 · LIQ
Orion Diagnostica, Inc.
Microbiology · 236d
Cleared Dec 14, 1994
BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER
K942434 · FRF
Bionaire Corp.
General Hospital · 208d
Cleared Dec 14, 1994
ORTHODONITC METAL REINFORCED PLASTIC BRACKET
K942826 · DYW
Gac Intl., Inc.
Dental · 183d
Cleared Dec 14, 1994
GLYCAR TISSUE REPAIR PATCH
K942911 · FTL
Glycar, Inc.
General & Plastic Surgery · 176d
Cleared Dec 14, 1994
ADOBE C.I.C
K943016 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 173d
Cleared Dec 14, 1994
ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)
K943740 · FMI
Premium Plastics, Inc.
General Hospital · 134d
Cleared Dec 14, 1994
MX4000
K943794 · FMI
Bfi- Medical Waste Systems
General Hospital · 133d
Cleared Dec 14, 1994
THE VIVACARE T.P.S. PROBE
K944848 · EIX
Rms Div.
Dental · 75d
Cleared Dec 14, 1994
NRF SYSTEM
K944973 · JAA
Philips Medical Systems (Cleveland),...
Radiology · 64d
Cleared Dec 14, 1994
PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL
K945018 · EBF
Pulpdent Corp.
Dental · 62d
Cleared Dec 14, 1994
HARKEN ASSURE SELF-SEAL STERILIZATION POUCH
K945055 · KCT
Harken Products, Inc.
General Hospital · 61d
Cleared Dec 14, 1994
PULPDENT RESIN CEMENT
K945056 · EBF
Pulpdent Corp.
Dental · 61d
Cleared Dec 14, 1994
PULPDENT HYBRID ANTERIOR COMPOSITE
K945057 · EBF
Pulpdent Corp.
Dental · 61d
Cleared Dec 14, 1994
PULPDENT MICROFILLED ANTERIOR COMPOSITE
K945058 · EBF
Pulpdent Corp.
Dental · 61d
Cleared Dec 14, 1994
PULPDENT DUAL CURE UNFILLED BONDING RESIN
K945112 · KLE
Pulpdent Corp.
Dental · 57d
Cleared Dec 14, 1994
PULPDENT CERVICAL RESTORATIVE
K945113 · EBF
Pulpdent Corp.
Dental · 57d
Cleared Dec 14, 1994
RHODIUM FILTER
K945272 · IZH
Lorad Corp.
Radiology · 47d
Cleared Dec 14, 1994
PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2
K945273 · FMI
Pro-Tec Containers, Inc.
General Hospital · 47d
Cleared Dec 14, 1994
PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80
K945274 · FMI
Pro-Tec Containers, Inc.
General Hospital · 47d