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
81241–81264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 2000
BIOTRACE, MODEL 1730
K002063 · MYU
Bryan Corp.
Neurology · 34d
Cleared Aug 10, 2000
INVACARE LIFT CHAIR
K002171 · INO
Invacare Corp.
Physical Medicine · 22d
Cleared Aug 10, 2000
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
K002190 · GAM
Cp Medical
General & Plastic Surgery · 21d
Cleared Aug 10, 2000
CARONY
K002205 · IOR
Bruno Independent Living Aids, Inc.
Physical Medicine · 20d
Cleared Aug 10, 2000
ELECSYS CA 15-3 CALCHECK
K002353 · JIS
Roche Diagnostics Corp.
Immunology · 8d
Cleared Aug 10, 2000
PROTEMP H
K002364 · EBG
Espe Dental AG
Dental · 7d
Cleared Aug 10, 2000
SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)
K994231 · ODA
Siemens Medical Corp.
Gastroenterology & Urology · 238d
Cleared Aug 09, 2000
IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
K000574 · EGJ
Wr Medical Electronics Co.
Physical Medicine · 169d
Cleared Aug 09, 2000
GOLDFINGER DEVICE
K001162 · FMK
Mali-Tech , Ltd.
General & Plastic Surgery · 121d
Cleared Aug 09, 2000
KWIKKMODEL
K001414 · ELW
R-Dental Dentalerzeugnisse GmbH
Dental · 97d
Cleared Aug 09, 2000
QUINTON Q-STRESS, MODEL 000483
K001492 · DPS
Quinton, Inc.
Cardiovascular · 89d
Cleared Aug 09, 2000
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
K001727 · BSZ
Blease Medical Equipment , Ltd.
Anesthesiology · 64d
Cleared Aug 09, 2000
HOTLINE 2 FLUID WARMER
K001764 · LGZ
Sims Level 1, Inc.
General Hospital · 58d
Cleared Aug 09, 2000
MODIFICATION TO PASCO MIC AND MIC/ID PANELS
K001887 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Aug 09, 2000
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K002012 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 37d
Cleared Aug 09, 2000
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K002015 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 37d
Cleared Aug 09, 2000
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
K002116 · DTQ
Medical Device Consultants, Inc.
Cardiovascular · 27d
Cleared Aug 09, 2000
STOCKERT COMPACT SYSTEM VERSION 2.0
K002118 · DTQ
Stoeckert Instrumente
Cardiovascular · 27d
Cleared Aug 09, 2000
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
K002221 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 16d
Cleared Aug 09, 2000
TRUE
K993913 · LIT
Infinity Extrusion & Engineering, Inc.
Cardiovascular · 266d
Cleared Aug 08, 2000
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
K000388 · KPL
Clearwater Colon Hydrotherapy, Inc.
Gastroenterology & Urology · 183d
Cleared Aug 08, 2000
LA JOIE
K000736 · HED
Goomi Ehwa, Inc.
Obstetrics & Gynecology · 154d
Cleared Aug 08, 2000
GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES,...
K001404 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 97d
Cleared Aug 08, 2000
HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
K001406 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 97d