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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
112081–112104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1993
MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI
K932375 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Sep 07, 1993
SIRESKOP CX
K932445 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Sep 07, 1993
HM-0970
K932720 · HRM
Hill-Med, Inc.
General & Plastic Surgery · 95d
Cleared Sep 07, 1993
CABOT MEDICAL OPTIMA HAND INSTRUMENTS
K932976 · GCJ
Cabot Medical Corp.
General & Plastic Surgery · 82d
Cleared Sep 07, 1993
CABOT MEDICAL OPTIMA HAND INSTRUMENTS
K932977 · GCJ
Cabot Medical Corp.
General & Plastic Surgery · 82d
Cleared Sep 07, 1993
FIBEROPTIC LIGHTSOURCES AND CARRIERS
K933145 · EQH
Electro Fiberoptics Corp.
Ear, Nose, Throat · 71d
Cleared Sep 07, 1993
POLYDOROS IS
K933240 · IZO
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Sep 07, 1993
PHILIPS 45 SERIES
K933850 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 32d
Cleared Sep 03, 1993
ACCELLON CERVICAL BIOSAMPLER
K911432 · HHT
Medscand AB
Obstetrics & Gynecology · 885d
Cleared Sep 03, 1993
NATRACARE TAMPON
K914430 · HEB
Bodywise (Uk), Ltd.
Obstetrics & Gynecology · 700d
Cleared Sep 03, 1993
SUPER-FLOW TUBING
K922245 · HIF
Armm, Inc.
Obstetrics & Gynecology · 478d
Cleared Sep 03, 1993
FLEX FINDER GUIDEWIRE
K923755 · OCY
Flex Medics Corporation
Gastroenterology & Urology · 406d
Cleared Sep 03, 1993
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
K924163 · DRF
Boston Scientific Corp
Cardiovascular · 380d
Cleared Sep 03, 1993
CUTTER, SURGICAL
K925382 · GCJ
Mectra Laboratories, Inc.
General & Plastic Surgery · 315d
Cleared Sep 03, 1993
DUAL CHAMBER MIXING BAG
K926123 · KPE
Secure Medical, Inc.
General Hospital · 273d
Cleared Sep 03, 1993
SPACELABS MEDICAL PATIENT MONITOR
K930095 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 238d
Cleared Sep 03, 1993
COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
K930348 · FDX
Boston Scientific Corp
Gastroenterology & Urology · 221d
Cleared Sep 03, 1993
DURHAM
K930406 · FPA
Intl. Medical, Inc.
General Hospital · 220d
Cleared Sep 03, 1993
DURHAM
K930410 · FPA
Intl. Medical, Inc.
General Hospital · 220d
Cleared Sep 03, 1993
VITALMAX 800-C
K930559 · CCK
Pace Tech, Inc.
Anesthesiology · 212d
Cleared Sep 03, 1993
DURHAM
K930750 · FPA
Intl. Medical Consultants
General Hospital · 203d
Cleared Sep 03, 1993
DURHAM
K930751 · FPA
Intl. Medical Consultants
General Hospital · 203d
Cleared Sep 03, 1993
PRESSURE LIMITING ELBOW
K932797 · BTM
Engineered Medical Systems
Anesthesiology · 86d
Cleared Sep 03, 1993
SINGLE USE MANUAL RESUSCITATOR PEEP VALVE
K932799 · BYE
Engineered Medical Systems
Anesthesiology · 86d