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
9097–9120 of 17,754
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 29, 1997
ARTISAN PULSE LAVAGE SYSTEM
K972551 · FQH
Howmedica Corp.
General Hospital · 113d
Cleared Oct 29, 1997
ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE
K972757 · LZA
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 98d
Cleared Oct 29, 1997
TUTTNAUER TABLE-TOP AUTOCLAVE
K973550 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 41d
Cleared Oct 29, 1997
MSI PRESSURE INFUSOR
K973843 · KZD
Smith Assoc.
General Hospital · 21d
Cleared Oct 29, 1997
2 GALLON ALTERNATE CARE SHARPS CONTAINER
K973911 · FMI
Sage Products, Inc.
General Hospital · 15d
Cleared Oct 24, 1997
PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
K972621 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 102d
Cleared Oct 24, 1997
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · LHI
Baxter Healthcare Corp
General Hospital · 29d
Cleared Oct 23, 1997
BARIAIR
K955243 · FNM
Kinetic Concepts, Inc.
General Hospital · 708d
Cleared Oct 21, 1997
DIGIFLEX SURGICAL GLOVES
K972277 · KGO
Hms Services, Inc.
General Hospital · 125d
Cleared Oct 21, 1997
ALLIANCE RUBBER, EC-GRIP
K972801 · LYY
Alliance Rubber Products Sdn. Bhd.
General Hospital · 85d
Cleared Oct 21, 1997
PROVISION SURGICAL HELMET SYSTEM
K972832 · FYA
Depuy, Inc.
General Hospital · 83d
Cleared Oct 21, 1997
POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)
K973811 · LYY
Absolute Quality Leadership, Inc.
General Hospital · 14d
Cleared Oct 20, 1997
ULTRASOUND TRANSDUCER DRAPE
K970889 · KKX
Protek Medical Products, Inc.
General Hospital · 223d
Cleared Oct 20, 1997
ULTRASOUND TRANSDUCER DRAPE
K970893 · FYA
Protek Medical Products, Inc.
General Hospital · 223d
Cleared Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P
K972779 · MRZ
Alexander Mfg. Co.
General Hospital · 87d
Cleared Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
K972780 · MRZ
Alexander Mfg. Co.
General Hospital · 87d
Cleared Oct 20, 1997
REXAM FRACTURE RESISTANT POUCH
K973440 · KCT
Rexam Medical Packaging, Inc.
General Hospital · 40d
Cleared Oct 17, 1997
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
K970864 · FOZ
Arrow Intl., Inc.
General Hospital · 221d
Cleared Oct 17, 1997
MAGI ACUPUNCTURE NEEDLES
K972658 · MQX
Dong Bang, U.S.A.
General Hospital · 94d
Cleared Oct 17, 1997
DONG BANG ACUPUNCTURE NEEDLES
K972659 · MQX
Dong Bang, U.S.A.
General Hospital · 94d
Cleared Oct 10, 1997
AUTOMIX 3+3/AS COMPOUNDER SYSTEM
K961008 · LHI
Baxter Healthcare Corp
General Hospital · 577d
Cleared Oct 10, 1997
PACER MODEL 100 INFUSION CONTROLLER
K963136 · LDR
Health Watch, Inc.
General Hospital · 423d
Cleared Oct 10, 1997
LUBRIGLIDE
K973557 · KMJ
Qualis, Inc.
General Hospital · 21d
Cleared Oct 07, 1997
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION...
K972678 · FRN
Mcgaw, Inc.
General Hospital · 83d