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
8353–8376 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 25, 1999
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
K992062 · LZA
Safeskin Corp.
General Hospital · 68d
Cleared Aug 25, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
K992165 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 58d
Cleared Aug 25, 1999
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K992496 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 30d
Cleared Aug 25, 1999
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K992497 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 30d
Cleared Aug 24, 1999
NEPTUNE WASTE MANAGEMENT SYSTEM
K990037 · FYD
American Immuno Tech
General Hospital · 230d
Cleared Aug 24, 1999
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K992672 · FRN
Belmont Instrument Corp.
General Hospital · 14d
Cleared Aug 23, 1999
QS DELIVERY SYSTEM
K991254 · KYZ
Sub-Q, Inc.
General Hospital · 132d
Cleared Aug 23, 1999
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · FXX
Medline Industries, Inc.
General Hospital · 111d
Cleared Aug 23, 1999
PARSET, MODEL A10001E
K992104 · FPA
Rd Medical Mfg., Inc.
General Hospital · 62d
Cleared Aug 23, 1999
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
K992107 · LYZ
General Gloves Corp.
General Hospital · 62d
Cleared Aug 23, 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
K992299 · LZA
Pamitex Industries Sdn Bhd
General Hospital · 46d
Cleared Aug 20, 1999
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V....
K990236 · FOZ
Johnson & Johnson Medical, Div. of...
General Hospital · 207d
Cleared Aug 20, 1999
JOBST READY-TO-WEAR ARM SLEEVES
K991570 · DWL
Beiersdorf-Jobt, Inc.
General Hospital · 107d
Cleared Aug 20, 1999
INTRAVASCULAR ADMINISTRATION SET
K991932 · FPA
The Kipp Group
General Hospital · 73d
Cleared Aug 20, 1999
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
K991985 · FPA
Cook, Inc.
General Hospital · 67d
Cleared Aug 20, 1999
PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
K992361 · FYD
Pall Medical
General Hospital · 36d
Cleared Aug 18, 1999
DUTECK DIGITAL CLINICAL THERMOMETER
K992327 · FLL
Duteck Industrial Co., Ltd.
General Hospital · 37d
Cleared Aug 17, 1999
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS...
K992200 · LYY
Shen Wei (Usa), Inc.
General Hospital · 48d
Cleared Aug 17, 1999
BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K992337 · FMC
Mexpo Intl., Inc.
General Hospital · 35d
Cleared Aug 16, 1999
BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER...
K983298 · FYD
Buffalo Filter Co., Inc.
General Hospital · 329d
Cleared Aug 13, 1999
KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
K991958 · LJL
Kiel Laboratories, Inc.
General Hospital · 64d
Cleared Aug 12, 1999
AB2 MED-FLO SOLUTION SET
K984569 · FPA
Ab2 Medical Products, Llp
General Hospital · 232d
Cleared Aug 12, 1999
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
K991949 · KGO
La Glove (M) Sdn. Bhd.
General Hospital · 64d
Cleared Aug 12, 1999
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
K991950 · KGO
La Glove (M) Sdn. Bhd.
General Hospital · 64d