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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
89905–89928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1998
TYROSINE 50-HOUR REAGENT KIT
K970093 · CDR
Astoria-Pacific, Inc.
Chemistry · 433d
Cleared Mar 19, 1998
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
K973532 · CAF
Dhd Diemolding Healthcare Div.
Anesthesiology · 182d
Cleared Mar 19, 1998
DISPOSABLE ESOPHAGEAL STETHOSCOPE
K973839 · BZT
Catheter Research, Inc.
Anesthesiology · 162d
Cleared Mar 19, 1998
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
K974202 · LBH
Pulpdent Corp.
Dental · 129d
Cleared Mar 19, 1998
ORATEC SPINECATH INTRADISCAL CATHETER
K974464 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 113d
Cleared Mar 19, 1998
ELMED ESU 120 M/M DIGITAL
K974793 · GEI
Elmed, Inc.
General & Plastic Surgery · 87d
Cleared Mar 19, 1998
JENASCAN
K980001 · GEX
Jenoptik Laser, Optik, Systeme GmbH
General & Plastic Surgery · 76d
Cleared Mar 19, 1998
IL TEST HEPARIN
K980242 · KFF
Instrumentation Laboratory CO
Hematology · 55d
Cleared Mar 19, 1998
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
K980313 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 51d
Cleared Mar 19, 1998
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
K980523 · CHL
Diametrics Medical, Inc.
Chemistry · 37d
Cleared Mar 19, 1998
DERMIUM
K980561 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 34d
Cleared Mar 19, 1998
LD2000 SERIES
K980565 · LMA
General Scanning, Inc.
Radiology · 34d
Cleared Mar 19, 1998
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K980698 · DZE
Astra Tech, Inc.
Dental · 24d
Cleared Mar 19, 1998
A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR
K980824 · DXN
A&D Engineering, Inc.
Cardiovascular · 15d
Cleared Mar 18, 1998
INCL II ENDOSCOPE
K963642 · GWG
Sofamor Danek USA,Inc.
Neurology · 552d
Cleared Mar 18, 1998
ELECSYS CA 125 II
K972162 · LTK
Boehringer Mannheim Corp.
Immunology · 282d
Cleared Mar 18, 1998
UFR FIBEROPTIC CABLE
K972225 · FST
Universal Fiberoptic Repair, Inc.
General & Plastic Surgery · 278d
Cleared Mar 18, 1998
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM
K973687 · MNH
Spinal Concepts, Inc.
Orthopedic · 173d
Cleared Mar 18, 1998
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
K974186 · JDW
Orthofix Srl
Orthopedic · 131d
Cleared Mar 18, 1998
ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER
K974544 · ITX
Aloka Co., Ltd.
Radiology · 104d
Cleared Mar 18, 1998
BIOZ.COM SYSTEM
K974725 · DSB
Cardiodynamics International Corp.
Cardiovascular · 90d
Cleared Mar 18, 1998
SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
K974726 · JXG
Elekta Implants, SA
Neurology · 90d
Cleared Mar 18, 1998
NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000
K974732 · GEX
Nidek, Inc.
General & Plastic Surgery · 90d
Cleared Mar 18, 1998
DEPUY TRI-LOCK HIP STEM
K974740 · LPH
Depuy, Inc.
Orthopedic · 89d