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
143953–143976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1986
MICRO-TRACHEOSTOMY CARE KIT
K861645 · BTO
Aci Medical, Inc.
Anesthesiology · 9d
Cleared May 09, 1986
MODIFIED BAROMED BREATHING PRESSURE MONITOR
K861720 · CAP
Draeger Medical, Inc.
Anesthesiology · 4d
Cleared May 09, 1986
AS165 RESPIRATION MONITOR
K861743 · BZQ
Air-Shields, Inc.
Anesthesiology · 3d
Cleared May 08, 1986
MEADOS INTRAORTIC GRAFT
K841596 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 750d
Cleared May 08, 1986
RUB E-Z
K854396 · GYA
E-Z Instruments Co.
Neurology · 189d
Cleared May 08, 1986
ECG MONITORING/DEFIBRILLATION ELECTRODE
K854433 · DRX
Andover Medical, Inc.
Cardiovascular · 184d
Cleared May 08, 1986
VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER
K854610 · DQY
Gish Biomedical, Inc.
Cardiovascular · 171d
Cleared May 08, 1986
ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS
K860652 · JOP
Hewlett-Packard Co.
Cardiovascular · 76d
Cleared May 08, 1986
BIOMECCA CARETAKER 1000 & 2000
K860790 · DPS
Biomecca Australia , Ltd.
Cardiovascular · 65d
Cleared May 08, 1986
PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337
K860805 · DQO
Gould, Inc.
Cardiovascular · 65d
Cleared May 08, 1986
EM STRESS ELECTRODE
K860827 · DRX
Electromed Intl., Ltd.
Cardiovascular · 64d
Cleared May 08, 1986
EXER-STIM 2
K861501 · GZJ
Th Charters, Inc.
Neurology · 15d
Cleared May 08, 1986
SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS
K861533 · FTC
Sunfit, Inc.
General & Plastic Surgery · 14d
Cleared May 08, 1986
COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED
K861678 · FNJ
Sierra Corp.
General Hospital · 7d
Cleared May 07, 1986
DJ UNIPOLAR
K853566 · DTB
Biotronik Sales, Inc.
Cardiovascular · 254d
Cleared May 07, 1986
DJP UNIPOLAR
K853567 · DTB
Biotronik Sales, Inc.
Cardiovascular · 254d
Cleared May 07, 1986
MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901
K853754 · LHO
Victoreen, Inc.
Radiology · 240d
Cleared May 07, 1986
DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE
K853996 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 219d
Cleared May 07, 1986
MEADOX MEDICALS INC. GRAFT SIZER
K854431 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 183d
Cleared May 07, 1986
TDK ECG ELECTRODE MEL-08-09 & -11
K854596 · DRS
Tdk Corp.
Cardiovascular · 170d
Cleared May 07, 1986
PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A
K854840 · DPS
Ivy Biomedical Systems, Inc.
Cardiovascular · 154d
Cleared May 07, 1986
RMI RESPIRATORY GATING SYSTEM MODEL 301
K854976 · IXO
Radiation Measurements, Inc.
Radiology · 146d
Cleared May 07, 1986
MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR
K860025 · KPR
Medicor USA , Ltd.
Radiology · 124d
Cleared May 07, 1986
MULTI PURPOSE MODEL 76-903
K860260 · LHO
Victoreen, Inc.
Radiology · 103d