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
7729–7752 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 05, 2001
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
K002201 · CAH
Sims Portex, Inc.
General Hospital · 200d
Cleared Feb 05, 2001
INTRAVASCULAR ADMINISTRATION SET
K003854 · FPA
Infusion Devices, Inc.
General Hospital · 54d
Cleared Feb 02, 2001
SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS
K001965 · FMI
North American Medical Products, Inc.
General Hospital · 219d
Cleared Feb 01, 2001
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 86d
Cleared Feb 01, 2001
POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM...
K003737 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 59d
Cleared Feb 01, 2001
CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
K003840 · FYD
I.C Medical, Inc.
General Hospital · 51d
Cleared Jan 29, 2001
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
K010078 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 19d
Cleared Jan 26, 2001
FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING...
K002719 · LYY
Tillotson Healthcare Corp.
General Hospital · 148d
Cleared Jan 26, 2001
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K003055 · LYY
Medline Industries, Inc.
General Hospital · 116d
Cleared Jan 26, 2001
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN...
K003653 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 60d
Cleared Jan 26, 2001
PATIENT DRAPE, SURGICAL
K003670 · KKX
Advance Medical Designs, Inc.
General Hospital · 59d
Cleared Jan 26, 2001
MEDCOMP Z-CATH
K003682 · LJS
Medical Components, Inc.
General Hospital · 57d
Cleared Jan 26, 2001
TIANXIE
K003748 · MQX
Suzhou Tianyi Acupuncture Instruments...
General Hospital · 53d
Cleared Jan 26, 2001
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200...
K003934 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 37d
Cleared Jan 26, 2001
GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT...
K010054 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 18d
Cleared Jan 26, 2001
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
K010072 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 17d
Cleared Jan 24, 2001
KENDALL-LTP TURNER SAVE-A-LINE
K003511 · FRP
The Ludlow Company LP
General Hospital · 71d
Cleared Jan 24, 2001
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K003904 · LYY
Purna Bina Sdn Bhd
General Hospital · 36d
Cleared Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034 · FOZ
Cook, Inc.
General Hospital · 20d
Cleared Jan 24, 2001
NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE
K010038 · FMI
Cambridge Marketing, Inc.
General Hospital · 19d
Cleared Jan 24, 2001
BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
K991618 · FRC
Propper Mfg. Co., Inc.
General Hospital · 624d
Cleared Jan 23, 2001
MEDLINE STERILIZATION WRAP
K002968 · FRG
Medline Industries, Inc.
General Hospital · 123d
Cleared Jan 23, 2001
GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K003872 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 39d
Cleared Jan 17, 2001
X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING...
K003895 · KGO
Ansell Perry
General Hospital · 30d