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
9121–9144 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 07, 1997
PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K973059 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 81d
Cleared Nov 07, 1997
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
K973301 · MEG
Retractable Technologies, Inc.
General Hospital · 66d
Cleared Nov 06, 1997
POLY (VINYL) EXAM GLOVE, POWDER-FREE
K972624 · LYZ
Copioumed Intl., Inc.
General Hospital · 115d
Cleared Nov 06, 1997
OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED
K973134 · LYY
Omnigrace , Ltd.
General Hospital · 77d
Cleared Nov 06, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973551 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 48d
Cleared Nov 05, 1997
POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
K972090 · LZA
Shen Wei (Usa), Inc.
General Hospital · 154d
Cleared Nov 05, 1997
VITALMIX PLUS EMPTY I.V. CONTAINER
K972464 · KPE
Pacific Device, Inc.
General Hospital · 127d
Cleared Nov 05, 1997
MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM
K973012 · FMI
MDC Research , Ltd.
General Hospital · 84d
Cleared Nov 04, 1997
SMARTVAC SMOKE EVACUATION SYSTEM
K970352 · FYD
Isomedix Operations, Inc.
General Hospital · 278d
Cleared Oct 30, 1997
ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300
K972878 · FMF
Safety Syringes, Inc.
General Hospital · 87d
Cleared Oct 30, 1997
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL...
K972885 · FMT
Fisher & Paykel Electronics , Ltd.
General Hospital · 86d
Cleared Oct 29, 1997
SPOROX
K970230 · MED
Reckitt Benckiser, Inc.
General Hospital · 281d
Cleared Oct 29, 1997
REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE
K971514 · LYY
London International Group, Inc.
General Hospital · 187d
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