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
150793–150816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1984
ABDOMINAL PARACENTESIS TRAY
K842009 · FSM
Jayco Pharmaceuticals
General & Plastic Surgery · 159d
Cleared Oct 23, 1984
HEMO STATIC/ESU SCALPEL SYSTEM
K842622 · GEI
Oximetrix, Inc.
General & Plastic Surgery · 110d
Cleared Oct 23, 1984
CST
K842818 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 97d
Cleared Oct 23, 1984
RETIC-CHEX
K843093 · JPK
Streck Laboratories, Inc.
Hematology · 77d
Cleared Oct 23, 1984
REPTILASE -PC
K843207 · JCO
Bio/Data Corp.
Hematology · 69d
Cleared Oct 23, 1984
OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR
K843422 · BSF
Ohmeda Medical
Anesthesiology · 53d
Cleared Oct 23, 1984
SCIMED PM200 INFLATION MANOMETER
K843448 · MAV
Scimed Life Systems, Inc.
Cardiovascular · 48d
Cleared Oct 23, 1984
MSI SURGI-GRADE INCISION & DRAIN TRAY
K843563 · FSM
Medical Sterilization, Inc.
General & Plastic Surgery · 43d
Cleared Oct 23, 1984
CATHETER INTRODUCER SYSTEM
K843641 · DYB
Xanmed Corp.
Cardiovascular · 36d
Cleared Oct 23, 1984
SUBCLAVIAN LEAD INTRODUCER SYS
K843642 · DYB
Xanmed Corp.
Cardiovascular · 36d
Cleared Oct 23, 1984
CAMPYLOCACTER SUPPLEMENT
K843653 · JSJ
Institute Virion , Ltd.
Microbiology · 36d
Cleared Oct 23, 1984
STERILE INSTRUMENT TRAYS-VARIOUS
K843723 · FSM
E.M. Adams
General & Plastic Surgery · 29d
Cleared Oct 23, 1984
WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
K843785 · BTO
Intl. Medical Devices , Ltd.
Anesthesiology · 26d
Cleared Oct 23, 1984
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
K843935 · LIO
Syva Co.
Microbiology · 18d
Cleared Oct 23, 1984
BLOOD DILUTION VIAL
K844042 · GKL
American Scientific Products
Hematology · 6d
Cleared Oct 22, 1984
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT
K841088 · CFL
Nichols Institute Diagnostics
Chemistry · 223d
Cleared Oct 22, 1984
TSH RECEPTOR ANTIBODY KIT 125I TSH
K841580 · JZO
Clinetics Corp.
Chemistry · 188d
Cleared Oct 22, 1984
SALICYLATE ASSAY KIT
K842158 · DKJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 145d
Cleared Oct 22, 1984
UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC
K843282 · BWH
Rush Hampton Industries
Ear, Nose, Throat · 63d
Cleared Oct 22, 1984
MEDICA IIF-ANTI-THYROID ANTIBODY TEST
K843343 · JZO
Medical Diagnostics, Ca.
Immunology · 56d
Cleared Oct 22, 1984
AUTODYNAMIC COMPRESSION HIP SCREW-PLATE
K843449 · KTT
Mecron Medical Products, Inc.
Orthopedic · 47d
Cleared Oct 22, 1984
EPICARDIA, PC
K843513 · DSI
Medicomp, Inc.
Cardiovascular · 46d
Cleared Oct 22, 1984
RICHARD ARTHROSCOPE
K843604 · HRX
Richards Medical Co., Inc.
Orthopedic · 39d
Cleared Oct 22, 1984
ELISA FOR TOTAL IGE
K843710 · DGC
Scientific Research
Immunology · 31d