FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
3409–3432 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 10, 2015
KM Needles (Acupuncture Needle)
K142920 · MQX
K.M.S., Inc.
General Hospital · 245d
Cleared Jun 09, 2015
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
K150662 · FMI
Ypsomed AG
General Hospital · 88d
Cleared Jun 09, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K150593 · LZA
Hartalega Sdn Bhd
General Hospital · 92d
Cleared Jun 09, 2015
SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202...
K143520 · JOJ
Crosstex
General Hospital · 179d
Cleared Jun 05, 2015
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC)...
K150109 · FOZ
Arrow International (A Subsidiary of...
General Hospital · 136d
Cleared Jun 05, 2015
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K143715 · LYZ
Better Plastic Co., Ltd.
General Hospital · 158d
Cleared Jun 05, 2015
HumaPen Luxura
K142518 · FMF
Eli Lilly and Company
General Hospital · 270d
Cleared Jun 03, 2015
ACCU-CHEK Connect Diabetes Management App
K150910 · NDC
Roche Diabetes Care, Inc.
General Hospital · 61d
Cleared Jun 02, 2015
Safe'n'Sound Staked Passive Delivery System - Plajex version
K150562 · MEG
Nemera
General Hospital · 88d
Cleared May 29, 2015
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K143263 · LZH
Covidien
General Hospital · 197d
Cleared May 29, 2015
Instru-Safe Instrument Protection System
K142768 · KCT
Summit Medical, Inc.
General Hospital · 246d
Cleared May 28, 2015
Imed Technology Intravascular Administration Set, Imed Technology Extension Set
K150513 · FPA
Imed Technology, Inc.
General Hospital · 90d
Cleared May 22, 2015
DualCap
K142806 · QBP
Catheter Connections, Inc.
General Hospital · 235d
Cleared May 21, 2015
Vital-Port Vascular Access System Power Injectable Port
K150733 · LJT
Cook Incorporated
General Hospital · 62d
Cleared May 21, 2015
SmartGownTM surgical gown
K150151 · FYA
Cardinal Health 200, Inc.
General Hospital · 118d
Cleared May 19, 2015
U&U Bowie-Dick Test Pack
K143629 · JOJ
U&U Medical Technology Co, Ltd.
General Hospital · 148d
Cleared May 15, 2015
BioFlo Midline Catheter
K150407 · FOZ
Navilyst Medical, Inc.
General Hospital · 86d
Cleared May 14, 2015
SCIg60 Infuser, Infuset
K142319 · PKP
Emed Technologies Corporation
General Hospital · 267d
Cleared May 12, 2015
BLUE VINYL GLOVES POWDER FREE
K150224 · LYZ
Zibo Sanying Trade Co., Ltd.
General Hospital · 99d
Cleared May 08, 2015
MedSource Sharps Dart
K150333 · MMK
Medsource International, LLC
General Hospital · 87d
Cleared May 07, 2015
Gemini Bonded Sterilization Wrap
K143147 · FRG
Medline Industries, Inc.
General Hospital · 185d
Cleared May 05, 2015
Pasture 60S Surgical Mask
K141875 · FXX
Pasture Pharma Pte, Ltd.
General Hospital · 298d
Cleared May 01, 2015
Invictus Medical GelShield
K150243 · FMP
Invictus Medical, Inc.
General Hospital · 88d
Cleared May 01, 2015
2D Mercy TAPE & 3D Mercy TAPE
K142469 · PIR
Children'S Mercy Hospital
General Hospital · 240d