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
8641–8664 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 14, 1999
GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE
K983570 · LYY
Glove Seal Sdn Bhd
General Hospital · 93d
Cleared Jan 14, 1999
MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE
K983827 · LYY
Sinetimed Latex Sdn Bhd
General Hospital · 76d
Cleared Jan 14, 1999
VINYL EXAMINATION GLOVES, PREPOWDERED USP
K984094 · LYZ
Trans Ancient Products Co., Ltd.
General Hospital · 59d
Cleared Jan 14, 1999
TALKING DIGITAL THERMOMETER, MODEL KV-171
K984553 · FLL
K-Jump Health Co., Ltd.
General Hospital · 23d
Cleared Jan 13, 1999
SENSIFLEX POWDERFREE SURGEON'S GLOVE
K982957 · KGO
Terang Nusa Sdn Bhd
General Hospital · 142d
Cleared Jan 13, 1999
VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)
K983544 · LJS
Vygon Corp.
General Hospital · 96d
Cleared Jan 13, 1999
BLOSSOM POWDERED LATEX EXAMINATION GLOVES
K984040 · LYY
Mexpo Intl., Inc.
General Hospital · 62d
Cleared Jan 13, 1999
OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM
K984066 · KGO
Omni Intl., Inc.
General Hospital · 58d
Cleared Jan 13, 1999
MICROSTAT 2
K984485 · LRJ
Chemlink Laboratories, LLC
General Hospital · 27d
Cleared Jan 12, 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · FRN
Abbott Laboratories
General Hospital · 207d
Cleared Jan 11, 1999
STERRAD 50 STERILIZER
K981625 · MLR
Advanced Sterilization Products
General Hospital · 249d
Cleared Jan 08, 1999
ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES
K983962 · KGO
Cardinal Health-Medical Products and...
General Hospital · 63d
Cleared Jan 08, 1999
UNIFINE
K983994 · FMF
Owen Mumford USA, Inc.
General Hospital · 60d
Cleared Jan 08, 1999
OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
K984064 · KGO
Omni Intl., Inc.
General Hospital · 53d
Cleared Jan 08, 1999
NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)
K984356 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 32d
Cleared Jan 04, 1999
STATIM 5000 CASSETTE AUTOCLAVE
K983679 · FLE
Scican
General Hospital · 76d
Cleared Dec 29, 1998
VARIABLE PRESSURE SYRINGE PUMP
K974332 · FRN
Alaris Medical Systems, Inc.
General Hospital · 406d
Cleared Dec 23, 1998
PROGUARD, RR-1, RR-2
K982832 · LZC
Emerson & Co. Srl
General Hospital · 133d
Cleared Dec 23, 1998
POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50...
K982897 · LYY
Pt. Maja Agung Latexindo
General Hospital · 128d
Cleared Dec 23, 1998
POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING...
K984019 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 41d
Cleared Dec 23, 1998
POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150...
K984020 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 41d
Cleared Dec 21, 1998
LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
K982901 · LYY
Vitalcare Group, Inc.
General Hospital · 126d
Cleared Dec 21, 1998
OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM...
K983568 · LYY
Contract Latex Dippers Sdn Bhd
General Hospital · 69d
Cleared Dec 21, 1998
OWEN MUMFORD 3ML AUTOPEN
K983974 · FMF
Owen Mumford USA, Inc.
General Hospital · 42d