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
82081–82104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 2000
STRYKER TRAUMA PLATING SYSTEM
K000636 · HRS
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared May 11, 2000
ERS RADIAL HEAD REPLACEMENT
K000658 · KWI
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared May 11, 2000
PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
K000694 · JDQ
Pectofix, Inc.
Orthopedic · 71d
Cleared May 11, 2000
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
K000706 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 70d
Cleared May 11, 2000
MD 10, SEM, SM 12, CBM
K000710 · EFB
NOUVAG AG
Dental · 70d
Cleared May 11, 2000
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965 · MNI
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared May 11, 2000
RESPIRATORY BELT SENSOR, MODEL 6000S
K001030 · BZQ
Dymedix, Inc.
Anesthesiology · 42d
Cleared May 11, 2000
MODEL 4300 PSARRAY EEG ELECTRODE SET
K001055 · GXY
Physiometrix, Inc.
Neurology · 38d
Cleared May 11, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K001145 · GKP
Dade Behring, Inc.
Hematology · 31d
Cleared May 11, 2000
JEL BIOS 90 (CODE NAME RD-2401)
K001196 · EJT
J.F. Jelenko & Co., Inc.
Dental · 29d
Cleared May 11, 2000
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
K001197 · DIO
OraSure Technologies, Inc.
Toxicology · 30d
Cleared May 11, 2000
XIA SPINE SYSTEM
K001272 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared May 11, 2000
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE...
K991886 · KRB
Pulsion Medical Systems, Inc.
Cardiovascular · 344d
Cleared May 11, 2000
WAND PLUS
K992819 · EJI
Spintech, Inc.
Dental · 265d
Cleared May 11, 2000
UNI-LASER 430
K993815 · GEX
Medart Corp.
General & Plastic Surgery · 183d
Cleared May 11, 2000
HEADLAMP HL2000.
K994362 · FSR
Angiolaz, Inc.
Ophthalmic · 136d
Cleared May 10, 2000
POSI-LINK
K000472 · FPA
Icu Medical, Inc.
General Hospital · 86d
Cleared May 10, 2000
RUMBAR DRAINAGE SYSTEM
K000514 · JXG
Phoenix Biomedical Corp.
Neurology · 84d
Cleared May 10, 2000
KEYSTONE HIP
K000521 · LPH
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared May 10, 2000
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
K001139 · DYB
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared May 10, 2000
COLORADO II SPINAL SYSTEM
K991031 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 408d
Cleared May 09, 2000
PSK ENDOSCOPE CLEANING SYSTEM
K000216 · FEB
Psk Connectors Pty, Ltd.
General Hospital · 106d
Cleared May 09, 2000
GO MEDICAL BALLOON INFUSION SYSTEM
K000263 · MEB
Go Medical Industries Pty. , Ltd.
General Hospital · 102d
Cleared May 09, 2000
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
K000328 · FRN
Medex, Inc.
General Hospital · 97d