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
106633–106656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1994
VITAL-PORT VASCULAR ACCESS SYSTEM
K934520 · LJT
Med Institute, Inc.
General Hospital · 351d
Cleared Sep 06, 1994
AUTO SUTURE DISPOSABLE ENDOSCOPE SHEATH
K934704 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 341d
Cleared Sep 06, 1994
ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES
K935281 · DRX
Arbo Medical, Inc.
Cardiovascular · 307d
Cleared Sep 06, 1994
ATOMSPEC GF BLOOD LEAD WORKSTATION
K936060 · DOF
Thermo Jarrell Ash Corp.Div.Thermo Inst.
Toxicology · 260d
Cleared Sep 06, 1994
VIRECTOMY LENS
K940107 · HJK
Visionary Technologies of Miami, Inc.
Ophthalmic · 239d
Cleared Sep 06, 1994
OCTOSTOP COMPENSATING FILTERS
K940306 · KPR
Octostop, Inc.
Radiology · 237d
Cleared Sep 06, 1994
DELFIA SHBG KIT
K940449 · CDZ
Wallac OY
Chemistry · 217d
Cleared Sep 06, 1994
BODY BOOT
K940723 · LYU
Mark-Clark
General Hospital · 200d
Cleared Sep 06, 1994
FLUIDS PACK FOR CORING 238
K940760 · JIX
Alko Diagnostic Corp.
Chemistry · 200d
Cleared Sep 06, 1994
SYRINGE FILTER DEVICES
K941589 · FMF
Gelman Sciences, Inc.
General Hospital · 159d
Cleared Sep 06, 1994
REVO ROTATOR CUFF REPAIR SYSTEM
K941691 · HRX
Linvatec Corp.
Orthopedic · 153d
Cleared Sep 06, 1994
PBI PLUS HDL PRECIPITATING REAGENT
K941744 · LBR
Merchant House Scientific
Chemistry · 152d
Cleared Sep 06, 1994
ELECTRONIC-AMPLIFIED STETHOSCOPE
K941763 · DQD
Hsues' Brothers Medical, Inc.
Cardiovascular · 148d
Cleared Sep 06, 1994
TECHNICUFF
K942259 · DXQ
Technicuff Corp.
Cardiovascular · 120d
Cleared Sep 06, 1994
SUNGLASSES
K942322 · HQY
Suntory Industrial Co.
Ophthalmic · 116d
Cleared Sep 06, 1994
DMA MICROPROTEIN PROCEDURE
K942424 · CEK
Data Medical Associates, Inc.
Chemistry · 109d
Cleared Sep 06, 1994
MODULE PROGRAM
K942722 · LRB
Electone, Inc.
Ear, Nose, Throat · 89d
Cleared Sep 06, 1994
PNEUMATIC WIRE TENSIONER
K942760 · HSZ
Smith & Nephew Richards, Inc.
Orthopedic · 85d
Cleared Sep 06, 1994
SPECTACLE FRAMES
K943039 · HQY
Rodenstock USA Inc.,
Ophthalmic · 71d
Cleared Sep 06, 1994
SPECTACLE FRAMES
K943423 · HQZ
Galilee Optics
Ophthalmic · 53d
Cleared Sep 06, 1994
(BRAND NAME0 MONDAIN
K943840 · HQY
Chan'S Plastic Manufactory Co., Ltd.
Ophthalmic · 32d
Cleared Sep 06, 1994
DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE
K943970 · GCJ
Cook Ob/Gyn
General & Plastic Surgery · 22d
Cleared Sep 06, 1994
HARPO SUNBED, SUN TANNING MACHINE
K944015 · LEJ
Harpo Industries
General & Plastic Surgery · 25d
Cleared Sep 02, 1994
PHYSIOTECH 4000 OR NORODYN 8000
K922270 · HCC
Myo-Tronics, Inc.
Neurology · 841d