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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,754 results
9409–9432 of 17,754
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 13, 1997
PEDIATRIC LIMB HOLDER
K963466 · FMQ
Deroyal Industries, Inc.
General Hospital · 163d
Cleared Feb 11, 1997
BEMIS TWO GALLON CHEMOTHERAPY CONTAINER
K964858 · MMK
Bemis Mfg. Co.
General Hospital · 69d
Cleared Feb 10, 1997
CVP POLYURETHANE CATHETER
K961552 · FOZ
Abbott Laboratories
General Hospital · 294d
Cleared Feb 10, 1997
OMNICAN SYRINGE
K962084 · FMF
B. Braun Medical AG
General Hospital · 257d
Cleared Feb 10, 1997
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
K963804 · LZA
Hartalega Sdn Bhd
General Hospital · 140d
Cleared Feb 10, 1997
SHARPS CONTAINER MODEL# SC001
K963830 · FMI
Image Medical, Inc.
General Hospital · 139d
Cleared Feb 10, 1997
AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)
K963866 · LYY
Supertex Industrial, S.A. DE C.V.
General Hospital · 210d
Cleared Feb 10, 1997
NITRILE POWDER-FREE EXAMINATION GLOVES
K964628 · LZA
Shen Wei (Usa), Inc.
General Hospital · 83d
Cleared Feb 10, 1997
VINYL PATIENT EXAMINATION GLOVES
K964629 · LYZ
Arista Medi Prima
General Hospital · 83d
Cleared Feb 10, 1997
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
K964812 · FPA
Critical Device Corp.
General Hospital · 73d
Cleared Feb 10, 1997
SEIRIN PYONEX ACUPUNCTURE NEEDLES
K970254 · MQX
Seirin-America, Inc.
General Hospital · 19d
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