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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
127561–127584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 1990
INSULATION PAD
K896307 · DWS
Bio-Vascular, Inc.
Cardiovascular · 80d
Cleared Jan 19, 1990
USCI PRESTO DISPOSABLE INFLATION DEVICE
K896415 · DXT
C.R. Bard, Inc.
Cardiovascular · 72d
Cleared Jan 19, 1990
WOUND DRESSING
K896702 · FRO
Viaderm Pharmaceuticals, Inc.
General & Plastic Surgery · 52d
Cleared Jan 19, 1990
DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF
K896788 · DXQ
Advanced Medical Instruments, Inc.
Cardiovascular · 46d
Cleared Jan 19, 1990
IGF-I BY EXTRACTION
K896808 · CFL
Nichols Institute Diagnostics
Chemistry · 46d
Cleared Jan 19, 1990
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K896819 · KRA
Baxter Healthcare Corp
Cardiovascular · 46d
Cleared Jan 19, 1990
CLINISTAT TOTAL PROTEIN REAGENT TEST
K896916 · CEK
Heraeus Kulzer, Inc.
Chemistry · 39d
Cleared Jan 19, 1990
MILENIA (TM) TSH
K900014 · JLW
Diagnostic Products Corp.
Chemistry · 17d
Cleared Jan 18, 1990
FIVE-YEAR STERILE PACKAGING SHELF LIFE
K892528 · DTB
Daig Corp.
Cardiovascular · 282d
Cleared Jan 18, 1990
POLYSTAN HEATER-COOLER UNIT
K893940 · DWC
Polystan C/O Vitalcor, Inc.
Cardiovascular · 232d
Cleared Jan 18, 1990
ASTRO-MED ASC-951 PRESSURE PROCESSOR
K894295 · DRQ
Astro-Med, Inc.
Cardiovascular · 209d
Cleared Jan 18, 1990
INAMED RHEMO-D (TM) DILATOR
K894618 · FFP
Inamed Development Co.
Gastroenterology & Urology · 182d
Cleared Jan 18, 1990
CARDIOPHONE
K894856 · DXH
Euro-American Marketing Group, Inc.
Cardiovascular · 171d
Cleared Jan 18, 1990
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
K895648 · JIT
Ventrex Laboratories, Inc.
Chemistry · 120d
Cleared Jan 18, 1990
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
K895649 · JIT
Ventrex Laboratories, Inc.
Chemistry · 120d
Cleared Jan 18, 1990
DEFIB K-PADS
K895662 · LDD
Katecho, Inc.
Cardiovascular · 120d
Cleared Jan 18, 1990
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
K895905 · JJY
Bio-Rad
Toxicology · 104d
Cleared Jan 18, 1990
PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM
K896034 · DSB
D. E. Hokanson, Inc.
Cardiovascular · 94d
Cleared Jan 18, 1990
MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR
K896102 · DXN
Advanced Medical Products, Inc.
Cardiovascular · 87d
Cleared Jan 18, 1990
MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR
K896103 · DSI
Advanced Medical Products, Inc.
Cardiovascular · 87d
Cleared Jan 18, 1990
IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC
K896150 · IYO
Teknar, Inc.
Radiology · 87d
Cleared Jan 18, 1990
HEMOGLOBIN A2 MICRO COLUMN TEST
K896168 · JPD
Bio-Rad
Hematology · 85d
Cleared Jan 18, 1990
KALOS 05 PULSE GENERATOR
K896184 · DXY
Biotronik Cardiac Pacemakers
Cardiovascular · 85d
Cleared Jan 18, 1990
CYSTO PUMP DRAINAGE BAG
K896208 · KOD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d