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
141481–141504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1986
MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE
K864413 · KNS
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 09, 1986
CARETEX ISOLUTION GOWNS
K864479 · FYC
James River Corp.
General Hospital · 26d
Cleared Dec 09, 1986
HOWSE II TOTAL HIP REPLACEMENT SYSTEM
K864508
Johnson & Johnson Professionals, Inc.
Orthopedic · 25d
Cleared Dec 08, 1986
CRITICALC
K860854 · DQK
Cygnus of South Florida, Inc.
Cardiovascular · 276d
Cleared Dec 08, 1986
TRACKER SYSTEM
K860948 · CGA
Boehringer Mannheim Corp.
Chemistry · 271d
Cleared Dec 08, 1986
EXACTECH(TM)
K863468 · CGA
Travenol Laboratories, S.A.
Chemistry · 91d
Cleared Dec 08, 1986
EM II DISPOSABLE ELECTRODE
K863540 · DRX
Electromed Intl., Ltd.
Cardiovascular · 88d
Cleared Dec 08, 1986
EM II STRESS TEST ELECTRODE
K863584 · DRX
Electromed Intl., Ltd.
Cardiovascular · 84d
Cleared Dec 05, 1986
DSP100 AMPLIFIER
K860814 · DQC
Intl. Acoustics, Inc.
Cardiovascular · 276d
Cleared Dec 05, 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 158d
Cleared Dec 05, 1986
AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY)
K862697 · DSY
Advanced Vascular Technologies, Inc.
Cardiovascular · 143d
Cleared Dec 05, 1986
ULTRA SOFTWARE MODULE: MODEL 2016
K863046 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 115d
Cleared Dec 05, 1986
EPICARDIA, PC/FD
K863643 · DSI
Medicomp, Inc.
Cardiovascular · 78d
Cleared Dec 05, 1986
DURACATH, GISH MODEL NO. DVAC-XXXX
K863792 · BSO
Gish Biomedical, Inc.
Anesthesiology · 70d
Cleared Dec 05, 1986
TUBULICID BLUE LABEL
K864050 · LBH
Dental Dimensions Supply Co.
Dental · 50d
Cleared Dec 05, 1986
TUBULITEC PRIMER
K864052 · LBH
Dental Dimensions Supply Co.
Dental · 50d
Cleared Dec 05, 1986
TUBULITEC LINER
K864053 · EJK
Dental Dimensions Supply Co.
Dental · 50d
Cleared Dec 05, 1986
TELECTRONICS SREW-IN/SLIM LINE PACING LEADS
K864098 · DTB
Daig Corp.
Cardiovascular · 45d
Cleared Dec 05, 1986
AQUAVALVE
K864147 · BYH
Respiratory Care, Inc.
Anesthesiology · 44d
Cleared Dec 05, 1986
EMERSON 3MV VOLUME VENTILATOR
K864394
J. H. Emerson Co.
Anesthesiology · 29d
Cleared Dec 05, 1986
MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER
K864428 · DTB
Intermedics, Inc.
Cardiovascular · 23d
Cleared Dec 05, 1986
MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD
K864564 · DTB
Intermedics, Inc.
Cardiovascular · 16d
Cleared Dec 05, 1986
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH
K864585 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 18d
Cleared Dec 04, 1986
DIGITAL PULSE METER HRM-100E & ETC.
K850449 · DRT
Sanyo Electric, Inc.
Cardiovascular · 667d