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
6673–6696 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 24, 2003
BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT)
K031928 · FLL
Braun GmbH
General Hospital · 123d
Cleared Oct 24, 2003
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
K031750 · LYZ
Kimberly-Clark Corp.
General Hospital · 141d
Cleared Oct 24, 2003
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
K031503 · FLL
Avita Corporation
General Hospital · 164d
Cleared Oct 23, 2003
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · LZG
Medtronic Minimed
General Hospital · 100d
Cleared Oct 22, 2003
CARDICARE MODEL MT-301F & MT-301C
K032714 · FLL
Lumiscope Co., Inc.
General Hospital · 50d
Cleared Oct 22, 2003
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
K032374 · LZC
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 82d
Cleared Oct 22, 2003
ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE
K023139 · KGO
Van Oostveen Medical B.V.
General Hospital · 397d
Cleared Oct 17, 2003
MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K032801 · JOJ
Albert Browne , Ltd.
General Hospital · 38d
Cleared Oct 17, 2003
SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES
K032746 · LYZ
Shanghai Giantmax Plastic Product Corp.
General Hospital · 43d
Cleared Oct 17, 2003
SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES
K032745 · LYZ
Shanghai Giantmax Plastic Product Corp.
General Hospital · 43d
Cleared Oct 17, 2003
MAXTER STERILE POWDER FREE SURGICAL GLOVES
K032501 · KGO
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 65d
Cleared Oct 16, 2003
ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109
K033099 · FPA
Applied Diabetes Research, Incorporated
General Hospital · 17d
Cleared Oct 16, 2003
MODEL IR 1200 INSULIN PUMP
K032257 · LZG
Animas Corp.
General Hospital · 86d
Cleared Oct 16, 2003
POWDER FREE LATEX EXAM GLOVES
K031335 · LYY
Tan Sin Lian Industries Sdn. Bhd.
General Hospital · 171d
Cleared Oct 16, 2003
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294
K031012 · FRC
3M Company
General Hospital · 199d
Cleared Oct 15, 2003
PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW
K032792 · LYZ
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 37d
Cleared Oct 15, 2003
DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
K031408 · FYA
Deroyal
General Hospital · 163d
Cleared Oct 15, 2003
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
K031301 · KGO
Cardinalhealth
General Hospital · 174d
Cleared Oct 10, 2003
MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
K032467 · KGO
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 60d
Cleared Oct 10, 2003
RUBBERCARE POWDERED LATEX EXAMINATION GLOVES
K032201 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 84d
Cleared Oct 10, 2003
POWDER FREE VINYL EXAMINATION GLOVE
K032071 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 99d
Cleared Oct 09, 2003
UNOMEDICAL MONICA INFUSION SET
K032854 · FPA
Unomedical A/S
General Hospital · 27d
Cleared Oct 09, 2003
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD...
K032789 · FRN
American I.V. Products, Inc.
General Hospital · 31d
Cleared Oct 07, 2003
MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS
K033039 · MEB
Mckinley, Inc.
General Hospital · 8d