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
93193–93216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1997
PTCA GUIDEWIRE
K970376 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 123d
Cleared Jun 06, 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K970735 · LBS
Randox Laboratories, Ltd.
Chemistry · 108d
Cleared Jun 06, 1997
MODEL HNC NEUROVASCULAR ARRAY COIL
K970868 · MOS
Mri Devices Corp.
Radiology · 88d
Cleared Jun 06, 1997
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
K970880 · ESD
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 06, 1997
VISTA V-38 CIC
K970939 · ESD
Vista Labs
Ear, Nose, Throat · 85d
Cleared Jun 06, 1997
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
K971016 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 78d
Cleared Jun 06, 1997
MAICO MA52
K971080 · EWO
Bernafon-Maico, Inc.
Ear, Nose, Throat · 73d
Cleared Jun 06, 1997
NEURO PULSE II,III
K971143 · ETN
Aaron Medical Industries
Ear, Nose, Throat · 70d
Cleared Jun 06, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
K971240 · HEL
Alexander Mfg. Co.
Obstetrics & Gynecology · 65d
Cleared Jun 06, 1997
PROVOX 2 VOICE PROSTHESIS SYSTEM
K971244 · EWL
Atos Medical AB
Ear, Nose, Throat · 64d
Cleared Jun 06, 1997
SCIENTIFIC PLASTICS MODEL SP
K971299 · ESD
Scientific Plastics, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 06, 1997
INSTEAD, SOFTCUP
K971303 · HHE
Ultrafem, Inc.
Obstetrics & Gynecology · 59d
Cleared Jun 06, 1997
AQ OPIATES (MORPHINE) TEST
K971361 · DJG
Bionike Laboratories, Inc.
Toxicology · 56d
Cleared Jun 06, 1997
PRONE BREAST POSITIONING BOARD, MODEL #37-018
K971382 · IYE
Victoreen, Inc.
Radiology · 84d
Cleared Jun 06, 1997
WIDEX SENSO DIGITAL (MINI CANAL)
K971535 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 39d
Cleared Jun 06, 1997
RIONET HB-79P
K971693 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 30d
Cleared Jun 06, 1997
CONTINU-FLO SOLUTION SET
K971701 · FPA
Baxter Healthcare Corp
General Hospital · 29d
Cleared Jun 06, 1997
PHILIPS S1694, S1695
K971804 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 23d
Cleared Jun 05, 1997
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
K963064 · FFX
Laborie Medical Tech Corp.
Gastroenterology & Urology · 302d
Cleared Jun 05, 1997
GORE IRRIGATION SET
K964067 · FPA
W.L. Gore & Associates, Inc.
General Hospital · 238d
Cleared Jun 05, 1997
STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000)
K965180 · GEX
Myriad Lase, Inc.
General & Plastic Surgery · 163d
Cleared Jun 05, 1997
LAMIN-2 HYDRATING GEL
K970153 · MGQ
Procyte Corp.
General & Plastic Surgery · 140d
Cleared Jun 05, 1997
GLARE WARE
K970816 · HQY
Ergovision, Inc.
Ophthalmic · 91d
Cleared Jun 05, 1997
INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K970843 · DSY
Intervascular, Inc.
Cardiovascular · 90d