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
143929–143952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1986
CASTALERT
K861292
Walgen Medical Innoventions
Orthopedic · 35d
Cleared May 12, 1986
CHURCHILL INJECTION SITE
K861430 · FPA
Churchill Corp.
General Hospital · 26d
Cleared May 12, 1986
TECNOL PERSONAL SHOE COVER
K861528 · FXP
Technol, Inc.
General Hospital · 18d
Cleared May 12, 1986
MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE
K861560 · FMI
Medi Point, Inc.
General Hospital · 17d
Cleared May 12, 1986
SLR BIPOLAR HIP ENDOPROSTHESIS
K861566 · KWY
Dow Corning Wright
Orthopedic · 17d
Cleared May 12, 1986
SHORTENING OSTEOTOMY GUIDE
K861576 · HTH
Osteotomy Guide Co.
Orthopedic · 14d
Cleared May 12, 1986
CENTRIX PCR MOLAR MATRIX FORMS (BANDS)
K861581 · DZN
Centrix, Inc.
Dental · 13d
Cleared May 12, 1986
TOPICAL HYPERBARIC OXYGEN CHAMBER
K861593 · KPJ
Stephenson Industries, Inc.
General & Plastic Surgery · 13d
Cleared May 12, 1986
SPUNGUARD PLUS SURGICAL GOWN
K861600 · FYA
Kimberly-Clark Corp.
General Hospital · 13d
Cleared May 09, 1986
VICKERS MEDICAL MODEL 271 HEART RATE MONITOR
K854597 · DRT
Vickers , Ltd.
Cardiovascular · 172d
Cleared May 09, 1986
SALTZMAN STETHOSCOPE HEAD
K854771 · LDE
K & S Medicorp
Cardiovascular · 161d
Cleared May 09, 1986
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731
K854797 · DXN
Takeda Medical, Inc.
Cardiovascular · 158d
Cleared May 09, 1986
MONARK 869 ERGOMETER
K855102 · DSP
Equilibrated Bio Systems, Inc.
Cardiovascular · 137d
Cleared May 09, 1986
MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT
K855107 · GZB
Medtronic Vascular
Neurology · 137d
Cleared May 09, 1986
BIOTEL (TM)/UTI
K855238 · JMT
American Diagnostic Corp.
Chemistry · 129d
Cleared May 09, 1986
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
K860124 · KLK
Mennen Medical, Inc.
Anesthesiology · 115d
Cleared May 09, 1986
FASTRACE III, ECG ELECTRODE
K860636 · DPS
Andover Medical, Inc.
Cardiovascular · 77d
Cleared May 09, 1986
HARIKY, MODEL GK-7
K860772 · GZJ
K-Mot, Inc.
Neurology · 67d
Cleared May 09, 1986
ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.)
K861139 · GEI
Conmedcorp
General & Plastic Surgery · 44d
Cleared May 09, 1986
MEDICOMP CPAP NASAL CANNULA
K861280 · BZD
Medicomp, Inc.
Anesthesiology · 32d
Cleared May 09, 1986
SPINNAKER
K861418 · BZC
Cybermedic, Inc.
Anesthesiology · 24d
Cleared May 09, 1986
CIRCUIT, ANES. BREATHING (NON-REBREATHING)
K861438 · CAI
Vital Signs, Inc.
Anesthesiology · 22d
Cleared May 09, 1986
SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS
K861559 · DXY
Cook Pacemaker Corp.
Cardiovascular · 14d
Cleared May 09, 1986
NEUROSURGICAL INSTURMENTS (VARIOUS)
K861630 · HAO
Downs Surgical , Ltd.
Neurology · 10d