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
155641–155664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1983
METABOLIC EXERCISE TESTING SYSTEM
K831780 · BZL
Warren E. Collins, Inc.
Anesthesiology · 102d
Cleared Sep 12, 1983
URODYNAMIC ANALYZER
K831788 · FAN
C.R. Bard, Inc.
Gastroenterology & Urology · 101d
Cleared Sep 12, 1983
PROTEX CONTRACEPT PLUS W/SPERM-LUB
K831816 · HIS
National Sanitary Laboratories, Inc.
Obstetrics & Gynecology · 98d
Cleared Sep 12, 1983
BALLOON DILATION HELICAL STONE EXTRACT
K831875 · FFL
Vpi
Gastroenterology & Urology · 91d
Cleared Sep 12, 1983
FEMORAL CANAL SPONGE
K831886 · NAB
Zimmer, Inc.
General & Plastic Surgery · 91d
Cleared Sep 12, 1983
DISPOSABLE FLOOR INSTRUMENTS
K831911 · KDC
Ormed Mfg., Inc.
General & Plastic Surgery · 90d
Cleared Sep 12, 1983
SAFETY PINS & RUBBER BANDS
K831915 · KDC
Ormed Mfg., Inc.
General & Plastic Surgery · 90d
Cleared Sep 12, 1983
THEOPHYLLINE TEST PACK ACA
K831934 · KLS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 89d
Cleared Sep 12, 1983
CREATINE KINASE REAGENT CK LTS
K831965 · CGS
Electro-Nucleonics Laboratories, Inc.
Chemistry · 84d
Cleared Sep 12, 1983
BIRTHWELL BIRTHING SYSTEM
K831998 · KNC
Qulab Co.
Obstetrics & Gynecology · 83d
Cleared Sep 12, 1983
STERILE SUTURE REMOVAL SET
K832047 · KDD
Ormed Mfg., Inc.
General & Plastic Surgery · 80d
Cleared Sep 12, 1983
ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV.
K832058 · KRA
Parke-Davis Co.
Cardiovascular · 77d
Cleared Sep 12, 1983
ACURACY 071, DENTAL, INTRAORAL-X-RAY
K832065 · EAP
Belmont Equipment Corp.
Radiology · 77d
Cleared Sep 12, 1983
VITA-MIST AIR COMPRESSOR & NEBULIZER
K832072 · BTI
Vita Medics
Anesthesiology · 76d
Cleared Sep 12, 1983
STERILE DISPOSABLE SYRINGE
K832101 · FMF
Lee Medical Intl., Inc.
General Hospital · 81d
Cleared Sep 12, 1983
STERILE DISP. BUTTERFLY INFUSION SET
K832104 · FPA
Lee Medical Intl., Inc.
General Hospital · 81d
Cleared Sep 12, 1983
ADMINISTRATIVE IV SET
K832105 · FPA
Lee Medical Intl., Inc.
General Hospital · 81d
Cleared Sep 12, 1983
NORMAC ANESTHETIC AGENT MONITOR
K832113 · CBS
Datex Division Instrumentarium Corp.
Anesthesiology · 74d
Cleared Sep 12, 1983
NEGATIVE PRESSURE CHEST RESPIRATOR PUMP
K832176 · BYT
J. H. Emerson Co.
Anesthesiology · 68d
Cleared Sep 12, 1983
METAVOX MV-1000 AUDITORY TRAINER
K832190 · EPF
Metavox, Inc.
Ear, Nose, Throat · 66d
Cleared Sep 12, 1983
VARIAN CLINACOMP 100 TISSUE COMPENSATOR
K832216 · IYE
Varian Assoc., Inc.
Radiology · 96d
Cleared Sep 12, 1983
EMERSON MODEL 3MV-AP AND 3V-AP PRESS-
K832271 · CAP
J. H. Emerson Co.
Anesthesiology · 62d
Cleared Sep 12, 1983
LIFECARE MICRO PUMP
K832289 · FRN
Abbott Laboratories
General Hospital · 61d
Cleared Sep 12, 1983
ENTERNAL FEEDING TUBE
K832293 · KNT
Concept, Inc.
Gastroenterology & Urology · 61d