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
144961–144984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1986
QUANTIMETRIC PLUS SUPPORT PACK
K855013 · DEH
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
K855049 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Feb 26, 1986
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
K855057 · DCN
Behring Diagnostics, Inc.
Immunology · 70d
Cleared Feb 26, 1986
SWANK ARTERIAL LINE BLOOD FILTER HF6000
K855066 · DTM
Cobe Laboratories, Inc.
Cardiovascular · 70d
Cleared Feb 26, 1986
SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100
K855067 · JOD
Cobe Laboratories, Inc.
Cardiovascular · 70d
Cleared Feb 26, 1986
S.L.T. CONTACT LASER SYSTEM
K855100 · LNK
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 65d
Cleared Feb 26, 1986
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
K855126 · DYB
Cordis Corp.
Cardiovascular · 65d
Cleared Feb 26, 1986
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
K855139 · LDF
Davis & Geck, Inc.
Cardiovascular · 65d
Cleared Feb 26, 1986
MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
K855145 · DRS
Gould, Inc.
Cardiovascular · 64d
Cleared Feb 26, 1986
BLOOD COLLECTING NEEDLE
K855248 · FMI
Churchill Corp.
General Hospital · 77d
Cleared Feb 26, 1986
MEDILOG 2500 SYSTEM
K860078 · DSI
Oxford Medilog, Inc.
Cardiovascular · 49d
Cleared Feb 26, 1986
MEDILOG 4500 SYSTEM
K860079 · DSI
Oxford Medilog, Inc.
Cardiovascular · 49d
Cleared Feb 26, 1986
OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
K860106 · CCE
American Bentley
Anesthesiology · 44d
Cleared Feb 26, 1986
MODEL MR-30 HOLTER RECORDER
K860181 · DSH
Oxford Medilog, Inc.
Cardiovascular · 36d
Cleared Feb 26, 1986
MODEL MR-35 HOLTER RECORDER
K860182 · DSH
Oxford Medilog, Inc.
Cardiovascular · 36d
Cleared Feb 26, 1986
AFT-HEP SYSTEM
K860183 · DHN
Behring Diagnostics, Inc.
Immunology · 36d
Cleared Feb 26, 1986
MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE
K860449 · FIE
Top Corp.
Gastroenterology & Urology · 22d
Cleared Feb 26, 1986
UNITY DISPOSABLE INCONTINENT BRIEF
K860459 · EYQ
Bevan Medical, Inc.
Gastroenterology & Urology · 20d
Cleared Feb 25, 1986
PK-AC POWERED PATIENT MANUPULATING DEVICE
K854058 · FNG
Mannesmann Demag Corp.
General Hospital · 145d
Cleared Feb 25, 1986
FIBRELIGHT ILLUMINATING ORAL RETRACTORS
K854711 · EIG
Downs Surgical , Ltd.
Dental · 95d
Cleared Feb 25, 1986
RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER
K854806 · FPA
Grant Medical Center
General Hospital · 85d
Cleared Feb 25, 1986
SINGLE AND DUAL TOURNIQUET CUFF
K860463 · KCY
Aspen Laboratories, Inc.
General & Plastic Surgery · 19d
Cleared Feb 24, 1986
VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES
K853101 · DSY
Cobe Laboratories, Inc.
Cardiovascular · 216d
Cleared Feb 24, 1986
CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK
K853400 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 199d