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
7777–7800 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 13, 2000
ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
K001233 · FPA
R-Group Intl.
General Hospital · 240d
Cleared Dec 13, 2000
CALEO
K003067 · FMZ
Drager Medizintechnik GmbH
General Hospital · 72d
Cleared Dec 13, 2000
GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
K003195 · SCL
Greer Laboratories, Inc.
General Hospital · 62d
Cleared Dec 13, 2000
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
K003283 · FPA
Sterling Medivations, Inc.
General Hospital · 55d
Cleared Dec 13, 2000
PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
K003611 · FRN
Breg, Inc.
General Hospital · 21d
Cleared Dec 12, 2000
SHENLING ACUPUNCTURE NEEDLES
K002411 · MQX
Shenling Medical Device Co., Ltd.
General Hospital · 127d
Cleared Dec 12, 2000
GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE...
K002569 · FMF
Malgam Ent., Inc.
General Hospital · 116d
Cleared Dec 12, 2000
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
K003616 · FRN
Baxter Healthcare Corp
General Hospital · 20d
Cleared Dec 08, 2000
NOVOFINE 31 DISPOSABLE NEEDLE
K002403 · FMI
Novo Norodisk Pharmaceuticals, Inc.
General Hospital · 123d
Cleared Dec 08, 2000
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE
K002691 · KKX
Com-Med International, Inc.
General Hospital · 101d
Cleared Dec 08, 2000
STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
K003002 · JOJ
Steritec Products, Inc.
General Hospital · 73d
Cleared Dec 05, 2000
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
K003582 · FRN
Fluidsense Corp.
General Hospital · 15d
Cleared Dec 04, 2000
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
K002391 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 122d
Cleared Dec 04, 2000
INFUSOMAT P
K003029 · FRN
B.Braun Medical, Inc.
General Hospital · 67d
Cleared Dec 04, 2000
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100...
K003245 · FOZ
Baxter Healthcare Corp
General Hospital · 48d
Cleared Dec 01, 2000
MEDCOMP BIO-CATH CATHETER LINE
K003110 · LJS
Medcomp
General Hospital · 58d
Cleared Nov 29, 2000
POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF...
K002593 · KGO
Hartalega Sdn Bhd
General Hospital · 100d
Cleared Nov 29, 2000
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
K002818 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 117d
Cleared Nov 29, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE
K002819 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 117d
Cleared Nov 29, 2000
EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124
K002861 · JOJ
Steritec Products, Inc.
General Hospital · 77d
Cleared Nov 29, 2000
B-D ULTRA-FINE III PEN NEEDLE
K002938 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 69d
Cleared Nov 29, 2000
ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50...
K003213 · LYY
Concept Rubber Products Sdn Bhd
General Hospital · 47d
Cleared Nov 28, 2000
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE...
K002064 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 144d
Cleared Nov 22, 2000
COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE...
K001613 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 181d