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
5737–5760 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 08, 2006
SHANGHAI GANGHAI MODEL GIKO 1400
K063334 · MSH
Shanghai Gangkai Purifying Products...
General Hospital · 32d
Cleared Dec 08, 2006
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT...
K063215 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 46d
Cleared Dec 08, 2006
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT...
K063214 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 46d
Cleared Dec 08, 2006
MANUAL PD-IO
K063142 · FMI
Vidacare Corporation
General Hospital · 53d
Cleared Dec 08, 2006
MEDTRONIC GRAFT DELIVERY SYRINGE
K062986 · FMF
Medtronic Sofamor Danek USA, Inc.
General Hospital · 70d
Cleared Dec 06, 2006
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1
K062867 · FLL
Microlife Intellectual Property GmbH
General Hospital · 72d
Cleared Dec 06, 2006
POWDER FREE LATEX EXAMINATION GLOVES, BLACK
K062709 · LYY
Pt. Maja Agung Latexindo
General Hospital · 86d
Cleared Dec 05, 2006
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT...
K063213 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 43d
Cleared Dec 05, 2006
EZ-MIO, EZ-IO DISTAL TIBIA
K062956 · FMI
Vidacare Corporation
General Hospital · 67d
Cleared Dec 05, 2006
ARJOWRAP 47/100 AND 47/88
K062100 · FRG
Arjo Wiggins Medical, Inc.
General Hospital · 134d
Cleared Dec 01, 2006
MEDICAN ALPHA
K063469 · FOZ
Eastern Medikit , Ltd.
General Hospital · 15d
Cleared Dec 01, 2006
PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S
K063013 · MSH
Aearo Company
General Hospital · 60d
Cleared Nov 30, 2006
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062688 · LYY
Ug Healthcare (Usa), Inc.
General Hospital · 83d
Cleared Nov 30, 2006
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
K062313 · LYY
Pt Mahakarya Inti Buana
General Hospital · 114d
Cleared Nov 29, 2006
ULTICARE DISPOSABLE SYRINGES AND NEEDLES
K062702 · FMF
Ultimed, Inc.
General Hospital · 79d
Cleared Nov 29, 2006
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
K062592 · FRN
Smiths Medical MD, Inc.
General Hospital · 89d
Cleared Nov 28, 2006
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
K063288 · FRN
Cardinal Health 303,Inc.
General Hospital · 27d
Cleared Nov 28, 2006
OMNIPICC P.I.
K062579 · LJS
Rita Medical Systems, Inc.
General Hospital · 89d
Cleared Nov 27, 2006
ACCU-CHEK LINKASSIST
K063146 · KZH
Disetronic Medical Systems AG
General Hospital · 42d
Cleared Nov 22, 2006
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES
K061517 · MQX
Prime Herbs Corporation
General Hospital · 174d
Cleared Nov 21, 2006
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22
K063291 · FLL
Choice Smart Health Care Co. , Ltd.
General Hospital · 20d
Cleared Nov 21, 2006
SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR
K063240 · LJS
C.R. Bard, Inc.
General Hospital · 26d
Cleared Nov 21, 2006
FLEXPEN NEEDLE
K062500 · FMI
Novo Nordisk, Inc.
General Hospital · 88d
Cleared Nov 21, 2006
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU
K050263 · FLE
M.O. Com S.R.L.
General Hospital · 655d