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
9457–9480 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 10, 1997
SEIRIN JR ACUPUNCTURE NEEDLES
K970260 · MQX
Seirin-America, Inc.
General Hospital · 18d
Cleared Feb 07, 1997
AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN)
K962737 · LYY
Supertex Industrial, S.A. DE C.V.
General Hospital · 207d
Cleared Feb 07, 1997
PATIENT EXAMINATION GLOVES
K964148 · LZA
Hartalega Sdn Bhd
General Hospital · 114d
Cleared Feb 07, 1997
DELTA N95 RESPIRATOR
K964722 · FXX
Racal Filter Technologies, Inc.
General Hospital · 74d
Cleared Feb 07, 1997
RACAL N95 RESIRATOR
K964723 · FXX
Racal Filter Technologies, Inc.
General Hospital · 74d
Cleared Feb 07, 1997
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K964964 · LYZ
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 58d
Cleared Feb 06, 1997
KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
K964401 · FMT
Ludlow Technical Products
General Hospital · 94d
Cleared Feb 03, 1997
TOTALCARE
K962942 · FNL
Hill-Rom, Inc.
General Hospital · 189d
Cleared Feb 03, 1997
ENTRACARE THERMOMTER MODEL 1000
K964851 · FLL
Entracare Corp.
General Hospital · 62d
Cleared Jan 30, 1997
STERILEMAX
K953938 · FLE
Barnstead/Thermolyne Corp.
General Hospital · 528d
Cleared Jan 30, 1997
P1OP2B OR P1O92T
K954674 · FYA
Kay Borch A/S
General Hospital · 478d
Cleared Jan 30, 1997
PATIENT EXAMINATION GLOVE
K961521 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 283d
Cleared Jan 30, 1997
DISETRONIC D-MODEM
K961975 · FRN
Disetronic Medical Systems
General Hospital · 255d
Cleared Jan 30, 1997
COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
K962288 · MMP
Pinnacle Products, Inc.
General Hospital · 230d
Cleared Jan 30, 1997
DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES
K962813 · KGO
Maxxim Medical
General Hospital · 195d
Cleared Jan 30, 1997
POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
K964455 · FPA
Medtronic Minimed
General Hospital · 85d
Cleared Jan 30, 1997
POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
K964456 · FPA
Medtronic Minimed
General Hospital · 85d
Cleared Jan 30, 1997
CW ACUPUNCTURE NEEDLES
K964529 · MQX
Lhasa Medical, Inc.
General Hospital · 79d
Cleared Jan 27, 1997
COMPLEAT SURGICAL MASK
K962654 · FXX
Carl Parker Associates, Inc.
General Hospital · 203d
Cleared Jan 27, 1997
THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE
K963675 · KKX
Micro-Medical Devices, Inc.
General Hospital · 136d
Cleared Jan 27, 1997
MODEL D-290P ADMINISTRATION SET
K964384 · FPA
Patient Solutions, Inc.
General Hospital · 84d
Cleared Jan 24, 1997
MEDTEXX
K963331 · LYY
Regalfield Sdn. Bhd.
General Hospital · 154d
Cleared Jan 24, 1997
SOMA SAFE ENCLOSURE
K963701 · FNL
Nova Technology Corp.
General Hospital · 130d
Cleared Jan 24, 1997
FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES
K964317 · LYY
Nantong Ruchang Latex Products Co., Ltd.
General Hospital · 87d