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
155905–155928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1983
EPCOM EMS-320 REMOTE MONITORSCOPE
K831115 · HGM
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 129d
Cleared Aug 12, 1983
INVAC W/VARIOUS MODELS
K831116 · GCX
Pmt
General Hospital · 129d
Cleared Aug 12, 1983
HEARCO C
K831129 · ESD
Hear Co., Inc.
Ear, Nose, Throat · 128d
Cleared Aug 12, 1983
DISPOS. ABODOMINAL RETRACTING PAD
K831130 · DWF
Product Development Corp.
Cardiovascular · 128d
Cleared Aug 12, 1983
GAUZE COMPRESS
K831281 · NAB
Pac-Kit Safety Equipment Co.
General & Plastic Surgery · 112d
Cleared Aug 12, 1983
BANDAGE COMPRESS
K831282 · NAB
Pac-Kit Safety Equipment Co.
General & Plastic Surgery · 112d
Cleared Aug 12, 1983
TRIANGLE BANDAGE STERILE
K831283 · NAD
Pac-Kit Safety Equipment Co.
General & Plastic Surgery · 112d
Cleared Aug 12, 1983
GAUZE BANDAGE
K831284 · NAB
Pac-Kit Safety Equipment Co.
General & Plastic Surgery · 112d
Cleared Aug 12, 1983
TRILEX
K831315 · FPB
Tri-Med, Inc.
General Hospital · 112d
Cleared Aug 12, 1983
IVFLO-HP & IVFIL-HP FILTER
K831350 · FPB
Tri-Med, Inc.
General Hospital · 109d
Cleared Aug 12, 1983
P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT
K831396 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 105d
Cleared Aug 12, 1983
PACELINE PATIENT TRANSMITTER MODEL 324
K831443 · DXH
Pacesetter Systems
Cardiovascular · 99d
Cleared Aug 12, 1983
API UNISCEPT PLUS 140 INOCULATOR
K831462 · JTC
Analytical Products, Inc.
Microbiology · 98d
Cleared Aug 12, 1983
SC-603 TWIN VALVE
K831486 · BTM
Instrumentation Industries, Inc.
Anesthesiology · 94d
Cleared Aug 12, 1983
DISP. TRANSDUCER W/MONITORING KIT TRANS
K831506 · DRS
Sorensen Research
Cardiovascular · 93d
Cleared Aug 12, 1983
URINE TOTAL PROTEIN CONTROL
K831526 · JJW
Quantimetrix Corp.
Chemistry · 92d
Cleared Aug 12, 1983
CUI MAMMARY PROTHESIS SIZER
K831566 · MRD
Cox-Uphuff Intl.
General & Plastic Surgery · 88d
Cleared Aug 12, 1983
PHYSIOLOGICAL MONITOR #902
K831578 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 87d
Cleared Aug 12, 1983
BAILEY ASPIRATOR/IRRIGATOR
K831584 · HQE
Medical Instrument Development...
Ophthalmic · 87d
Cleared Aug 12, 1983
MAXI SHIELDS
K831593 · HHD
Weyerhaeuser Co.
Obstetrics & Gynecology · 87d
Cleared Aug 12, 1983
INSPETOSCOPE
K831614 · ERA
Terayco Intl., Ltd.
Ear, Nose, Throat · 85d
Cleared Aug 12, 1983
GASTROSTOMY FEEDING SET
K831631 · KNT
Plasco, Inc.
Gastroenterology & Urology · 84d
Cleared Aug 12, 1983
FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE
K831659 · LIT
American Edwards Laboratories
Cardiovascular · 81d
Cleared Aug 12, 1983
SUPRAMID EXTRA SURGICAL MESH
K831723 · FTM
S. Jackson, Inc.
General & Plastic Surgery · 73d