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
7969–7992 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 15, 2000
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
K001082 · FYD
Stackhouse, Inc.
General Hospital · 72d
Cleared Jun 15, 2000
STERRAD 100S STERILIZER
K991999 · MLR
Advanced Sterilization Products
General Hospital · 367d
Cleared Jun 13, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100...
K001475 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 33d
Cleared Jun 13, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
K001485 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 32d
Cleared Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC...
K992532 · FOZ
Baxter Healthcare Corp
General Hospital · 320d
Cleared Jun 12, 2000
EUDERMIC PF POWDER-FREE SURGICAL GLOVES
K001343 · KGO
Maxxim Medical, Inc.
General Hospital · 46d
Cleared Jun 12, 2000
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING...
K001529 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 26d
Cleared Jun 12, 2000
MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
K001549 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 25d
Cleared Jun 12, 2000
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3...
K993518 · FOZ
Medefil, Inc.
General Hospital · 238d
Cleared Jun 09, 2000
MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
K000377 · LYY
Masif Healthcare Products Sdn. Bhd.
General Hospital · 123d
Cleared Jun 09, 2000
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML,...
K001287 · KPE
Sorenson Medical, Inc.
General Hospital · 46d
Cleared Jun 09, 2000
TERUMO U-100 INSULIN SYRING
K001474 · FMF
Terumo Medical Corp.
General Hospital · 29d
Cleared Jun 09, 2000
LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS...
K001557 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 21d
Cleared Jun 09, 2000
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR...
K994199 · KKX
Custom Medical Products, Inc.
General Hospital · 179d
Cleared Jun 08, 2000
UNIVEC TWO PIECE SYRINGE
K000747 · FMF
Univec, Inc.
General Hospital · 93d
Cleared Jun 08, 2000
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
K000813 · LZA
Allegiance Healthcare Coporation
General Hospital · 87d
Cleared Jun 08, 2000
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
K000842 · FRN
Sims Deltec, Inc.
General Hospital · 85d
Cleared Jun 08, 2000
PENADAPT 10
K000904 · FYD
Buffalo Filter Co., Inc.
General Hospital · 79d
Cleared Jun 06, 2000
THE WAND
K992404 · FMF
Spintech, Inc.
General Hospital · 323d
Cleared Jun 02, 2000
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
K001017 · MEG
Retrax Safety Systems, Inc.
General Hospital · 65d
Cleared Jun 01, 2000
HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID...
K000456 · FMF
Harvest Technologies, LLC
General Hospital · 111d
Cleared Jun 01, 2000
STERRAD BI TEST PACK
K993775 · FRC
Advanced Sterilization Products
General Hospital · 206d
Cleared May 31, 2000
RELIANCE FAMILY OF WASHER-DISINFECTORS
K983068 · LDS
STERIS Corporation
General Hospital · 637d
Cleared May 31, 2000
SURGEN VALVE
K990331 · FPA
Tiva Medical
General Hospital · 484d