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
9457–9480 of 17,754
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 09, 1997
SURETEMP
K964643 · FLL
Diatek Instruments, Inc.
General Hospital · 58d
Cleared Jan 07, 1997
UNIT-MATT 5000 PRESSURE RELIEF SYSTEM
K962585 · FNM
United Medical Equipment, Inc.
General Hospital · 190d
Cleared Jan 07, 1997
9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
K963620 · FNM
9th Wave, Inc.
General Hospital · 119d
Cleared Jan 06, 1997
SERAGARD VASCULAR ACCESS DEVICE
K963595 · FMI
Cutting Edge Technologies, Inc.
General Hospital · 119d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER KIT
K964048 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER WITH DUAL LUMENS
K964049 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER
K964050 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Jan 06, 1997
OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS
K964103 · DWL
Tournier-Bottu S.A.
General Hospital · 87d
Cleared Jan 03, 1997
N95 FILTERING FACEPIECE
K962443 · FXX
Survivair, Inc.
General Hospital · 193d
Cleared Jan 03, 1997
ROLL BELTS
K963467 · FMQ
Deroyal Industries, Inc.
General Hospital · 122d
Cleared Jan 03, 1997
PORTSMART NEEDLE DE-ACCESS ENCLOSURE
K964559 · LJT
Jireh, Inc.
General Hospital · 51d
Cleared Dec 31, 1996
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
K964127 · GCX
Allegiance Healthcare Corp.
General Hospital · 77d
Cleared Dec 31, 1996
TAKI ACUPUNCTURE NEEDLES
K964411 · MQX
Lhasa Medical, Inc.
General Hospital · 83d
Cleared Dec 31, 1996
ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
K964515 · FNL
M.C. Healthcare Products, Inc.
General Hospital · 76d
Cleared Dec 30, 1996
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM
K955425 · LYY
Dash Medical Gloves Sdn Bhd
General Hospital · 398d
Cleared Dec 30, 1996
ISOLATION GOWN
K960999 · FYC
Copioumed Intl., Inc.
General Hospital · 293d
Cleared Dec 30, 1996
SHOE COVER, NON-STERILE
K961342 · FXP
Copioumed Intl., Inc.
General Hospital · 285d
Cleared Dec 30, 1996
POWDER FREE VINYL EXAMINATION GLOVE
K964545 · LYZ
Shanghai Poseidon Plastic Products...
General Hospital · 47d
Cleared Dec 30, 1996
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K964563 · LYY
Omni Sales Corp.
General Hospital · 46d
Cleared Dec 24, 1996
NEO-CARE DUAL LUMEN UMBILICAL CATHETER
K963972 · FOS
Klein-Baker Medical, Inc.
General Hospital · 82d
Cleared Dec 24, 1996
COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE
K964060 · FMF
Travenol Laboratories (Israel) , Ltd.
General Hospital · 76d
Cleared Dec 23, 1996
MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT...
K960982 · FMI
Sherwood Medical Co.
General Hospital · 287d
Cleared Dec 23, 1996
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM
K962226 · FOZ
Johnson & Johnson Medical, Inc.
General Hospital · 196d
Cleared Dec 23, 1996
CONVERTORS DRAPE MATERIAL
K964125 · KKX
Allegiance Healthcare Corp.
General Hospital · 69d