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
7657–7680 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 11, 2001
FUNET AMY MAMA BODY THERMOMETER
K003326 · FLL
Funai Radio & Communications Corp.
General Hospital · 169d
Cleared Apr 11, 2001
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
K010462 · FLL
Avita Corporation
General Hospital · 54d
Cleared Apr 10, 2001
POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
K010486 · LZA
Pt. Medisafe Technologies
General Hospital · 49d
Cleared Apr 10, 2001
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
K010719 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 29d
Cleared Apr 10, 2001
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
K010767 · LJT
Horizon Medical Products, Inc.
General Hospital · 27d
Cleared Apr 09, 2001
POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K010671 · LYZ
Tong Ruhn Medical Products Co., Ltd.
General Hospital · 34d
Cleared Apr 09, 2001
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
K010830 · LYZ
General Gloves Corp.
General Hospital · 20d
Cleared Apr 06, 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · FRN
Abbott Laboratories
General Hospital · 10d
Cleared Apr 05, 2001
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE...
K003350 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 161d
Cleared Apr 05, 2001
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
K010377 · KZH
Minimed, Inc.
General Hospital · 56d
Cleared Apr 05, 2001
RECONSTITUTION KIT & VIAL CONNECTOR
K010623 · LHI
Bioject, Inc.
General Hospital · 34d
Cleared Apr 05, 2001
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
K010829 · LYZ
General Gloves Corp.
General Hospital · 16d
Cleared Apr 03, 2001
WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
K001892 · FXX
White Knight Healthcare, Inc.
General Hospital · 286d
Cleared Apr 03, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
K010110 · LZA
Shen Wei (Usa), Inc.
General Hospital · 81d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
K010860 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 12d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
K010861 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 12d
Cleared Apr 02, 2001
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
K001893 · FXX
White Knight Healthcare, Inc.
General Hospital · 285d
Cleared Apr 02, 2001
WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
K001997 · FXX
White Knight Healthcare, Inc.
General Hospital · 276d
Cleared Mar 30, 2001
SARSTEDT NEEDLE PROTECTOR
K003382 · FMI
Sarstedt, Inc.
General Hospital · 150d
Cleared Mar 30, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE...
K010097 · LZA
Shen Wei (Usa), Inc.
General Hospital · 78d
Cleared Mar 30, 2001
PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS...
K010538 · FPA
Rd Medical Mfg., Inc.
General Hospital · 35d
Cleared Mar 30, 2001
POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE
K010663 · LYZ
Tong Ruhn Medical Products Co., Ltd.
General Hospital · 24d
Cleared Mar 30, 2001
PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
K994381 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 458d
Cleared Mar 28, 2001
EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
K002705 · LHI
Baxa Corp.
General Hospital · 210d