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
6457–6480 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 28, 2004
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE
K041399 · FMI
Smiths Medical Asd, Inc.
General Hospital · 63d
Cleared Jul 28, 2004
SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040682 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 134d
Cleared Jul 26, 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K041420 · LJS
AngioDynamics, Inc.
General Hospital · 59d
Cleared Jul 22, 2004
THERMOTEK Q5
K041646 · FLL
Saat , Ltd.
General Hospital · 35d
Cleared Jul 22, 2004
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
K041345 · FOZ
Medix, Inc.
General Hospital · 63d
Cleared Jul 22, 2004
GETTIG UNIVERSAL VIAL ACCESS PIN
K041232 · LHI
Gettig Pharmaceutical Instrument Co.
General Hospital · 73d
Cleared Jul 19, 2004
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
K041318 · LZG
Medtronic Minimed
General Hospital · 62d
Cleared Jul 19, 2004
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
K041317 · LZG
Medtronic Minimed
General Hospital · 62d
Cleared Jul 16, 2004
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
K041564 · LHI
Bioject Medical Technologies, Inc.
General Hospital · 36d
Cleared Jul 16, 2004
OPEN BORE SYRINGE
K041344 · FMF
Isotis NV
General Hospital · 57d
Cleared Jul 16, 2004
EMPOWER TRANSFER SET, (CAT. NO. 7725)
K041178 · FPK
E-Z-Em, Inc.
General Hospital · 72d
Cleared Jul 16, 2004
SPLIT SEPTUM INJECTION SITES
K041042 · FPA
Fresenius Medical Care North America
General Hospital · 85d
Cleared Jul 15, 2004
VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
K041745 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 17d
Cleared Jul 15, 2004
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED
K041225 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 66d
Cleared Jul 15, 2004
CLIP-ON SPACER 20%
K041084 · FMF
Serono, Inc.
General Hospital · 80d
Cleared Jul 12, 2004
SHARPSAWAY II LOCKING DISPOSABLE CUP
K041153 · FMI
Arrow Intl., Inc.
General Hospital · 70d
Cleared Jul 12, 2004
PHYSICIAN INDUSTRIES' DURAMETER SYRINGE
K033739 · FMF
Physician Industries, Inc.
General Hospital · 227d
Cleared Jul 12, 2004
ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER
K033448 · FRA
John Mfg., Ltd.
General Hospital · 257d
Cleared Jul 09, 2004
BAXTER INFUSOR SV (SMALL VOLUME)
K041738 · FRN
Baxter Healthcare Corporation
General Hospital · 11d
Cleared Jul 09, 2004
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K041391 · LZA
Hartalega Sdn Bhd
General Hospital · 45d
Cleared Jul 08, 2004
CRONO AND CRONO, MODEL 30
K041414 · FRN
Cane S.R.L.
General Hospital · 42d
Cleared Jul 08, 2004
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · LZA
Medline Industries, Inc.
General Hospital · 98d
Cleared Jul 06, 2004
MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
K041241 · FRN
Alaris Medical Systems, Inc.
General Hospital · 56d
Cleared Jul 02, 2004
DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE
K041325 · LYZ
Est International Corporation
General Hospital · 45d