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
130009–130032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1989
MEDSCOPE 4MM ARTHROSCOPE
K894303 · HRX
Medscope Corp.
Orthopedic · 32d
Cleared Jul 25, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III
K894338 · GGC
Analytical Control Systems, Inc.
Hematology · 11d
Cleared Jul 25, 1989
MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
K894364 · JZO
Kronus
Immunology · 11d
Cleared Jul 24, 1989
NEOVO2R VENTILATORY
K885243 · BTM
Neomed
Anesthesiology · 214d
Cleared Jul 24, 1989
PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET
K890093 · KNT
Kells Medical, Inc.
Gastroenterology & Urology · 195d
Cleared Jul 24, 1989
ANGIOGRAPHY CUSTOM PACKS
K891572 · DTL
Procedure Packs, Inc.
Cardiovascular · 126d
Cleared Jul 24, 1989
DISPOSABLE MEDICAL GOWNS
K891820 · FYB
Bioshield, Inc.
General Hospital · 126d
Cleared Jul 24, 1989
M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ
K892355 · IYO
Hewlett-Packard Co.
Radiology · 98d
Cleared Jul 24, 1989
MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA
K892406 · CCK
Salter Labs
Anesthesiology · 108d
Cleared Jul 24, 1989
MODIFIED DEMAND NASAL OXYGEN CANNULA
K892407 · NFB
Salter Labs
Anesthesiology · 108d
Cleared Jul 24, 1989
KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
K892438 · FPA
The Kendal Co.
General Hospital · 105d
Cleared Jul 24, 1989
KENDALL CURITY EXTENSION TUBES
K892440 · FPA
The Kendal Co.
General Hospital · 105d
Cleared Jul 24, 1989
VINYL PATIENT EXAMINATION GLOVES
K892575 · LYZ
Foodhandler, Inc.
General Hospital · 105d
Cleared Jul 24, 1989
ENTERA-FLO SPIKE SET
K893209 · KNT
Delmed, Inc.
Gastroenterology & Urology · 88d
Cleared Jul 24, 1989
LATEX EXAMINATION GLOVES
K893295 · LYY
Lee AH Sheng Ent. Co., Ltd.
General Hospital · 97d
Cleared Jul 24, 1989
LATEX EXAMINATION GLOVES
K893296 · LYY
Midas Intl. Development Corp.
General Hospital · 97d
Cleared Jul 24, 1989
TWO TANK DISSOLUTION MODULE
K893612 · FKQ
National Medical Care, Medical...
Gastroenterology & Urology · 75d
Cleared Jul 24, 1989
HOLLOW FIBER DIALYZER FOCUS 70H
K893677 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 69d
Cleared Jul 24, 1989
SHUNT CONNECTORS
K893679 · FJQ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 69d
Cleared Jul 24, 1989
PERITONEAL DIALYSIS SYSTEM AND ACCESS.
K893712 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 67d
Cleared Jul 24, 1989
FILTRAL TM 20 HEMODIALYZER/FILTER
K893742 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 68d
Cleared Jul 24, 1989
ML-800 AUTOELECTRONIC LIGHT SOURCE
K893828 · FST
M.P. Video, Inc.
General & Plastic Surgery · 61d
Cleared Jul 24, 1989
LATEX EXAMINATION GLOVES
K893864 · LYY
In Medicine, Inc.
General Hospital · 60d
Cleared Jul 24, 1989
THORACENTISIS KIT
K894326 · GAA
Mill-Rose Laboratory
General & Plastic Surgery · 10d