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
134305–134328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1988
NEWBORN CALF SERUM, HEAT INACTIVATED # 110-1131
K883286 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
CALF SERUM, GAMMA IRRADIATED, CAT. NO. 110-1126
K883287 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
DONOR HORSE SERUM, HEAT INACTIVATED, #110-1113
K883288 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
CALF SERUM, HEAT INACTIVATED, CAT. # 110-1127
K883289 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
DONOR BOVINE SERUM, CAT. NO. 110-1116
K883290 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
DONOR HORSE SERUM, CAT. NO. 110-1110
K883291 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
BOVINE SERUM, CAT. LNO. 110-1115
K883292 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 12, 1988
SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT
K874544 · LGO
Molecular Biosystems, Inc.
Microbiology · 283d
Cleared Aug 12, 1988
BINAX EQUATE GLYCOHEMOGLOBIN
K874749 · LCP
Binax, Inc.
Hematology · 268d
Cleared Aug 12, 1988
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · DXO
Ohmeda Medical
Cardiovascular · 164d
Cleared Aug 12, 1988
KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH
K881667 · GBM
The Kendal Co.
Gastroenterology & Urology · 116d
Cleared Aug 12, 1988
GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER
K881723 · JOP
Biosound, Inc.
Cardiovascular · 113d
Cleared Aug 12, 1988
PROVIDER ONE INFUSION SYSTEM
K882102 · FRN
Pancretec, Inc.
General Hospital · 85d
Cleared Aug 12, 1988
EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40
K882137 · DTM
Medtronic Blood Systems, Inc.
Cardiovascular · 84d
Cleared Aug 12, 1988
MODIFIED TORAY FILTRYZER DIALYZERS
K882158 · FJI
Toray Industries (America), Inc.
Gastroenterology & Urology · 81d
Cleared Aug 12, 1988
MINIMON 7131B PATIENT MONITOR
K882197 · DPS
Kontron Instruments, Inc.
Cardiovascular · 79d
Cleared Aug 12, 1988
OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE
K882221 · DYB
Argon Medical Corp.
Cardiovascular · 78d
Cleared Aug 12, 1988
TRIAD ORTHODONTIC GEL
K882482 · EBI
Dentsply Intl.
Dental · 57d
Cleared Aug 12, 1988
ASTRA DENTAL IMPLANT SYSTEM
K882578 · DZE
Astra Meditec AB
Dental · 51d
Cleared Aug 12, 1988
REBUILDING STERILIZERS
K882713 · FLE
Mdt Corp., Inc.
General Hospital · 42d
Cleared Aug 12, 1988
PROFESSIONAL MODEL 7525 DELIVERY SYSTEM
K882759 · EFS
Viadent
Dental · 38d
Cleared Aug 12, 1988
CILCO VILLASENOR PACHYMETER
K882805 · IYO
Coopervision-Cilco
Radiology · 36d
Cleared Aug 12, 1988
EASY-OP, PORTABLE DENTAL CART
K882810 · EIA
Wy'East Medical Corp.
Dental · 36d
Cleared Aug 12, 1988
DENTAL FLOSS PICK
K882828 · JES
Bik Pik
Dental · 35d