FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,766 results
9985–10008 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 23, 1996
MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER
K953335 · FOZ
Micro Therapeutics, Inc.
General Hospital · 190d
Cleared Jan 23, 1996
EXTENSION SET WITH CHECK VALVE
K954983 · FPA
Distronic Sterile Products, Inc.
General Hospital · 84d
Cleared Jan 23, 1996
MINIBORE STOPCOCK SET
K954984 · FMG
Distronic Sterile Products, Inc.
General Hospital · 84d
Cleared Jan 23, 1996
POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM
K955029 · LYY
Shen Wei (Usa), Inc.
General Hospital · 82d
Cleared Jan 23, 1996
NULIFE
K955055 · LYY
Med-Tech Rubber & Engineering Industries
General Hospital · 81d
Cleared Jan 23, 1996
MAXI-FLOW
K955150 · BYY
Bio-Medical Devices, Inc.
General Hospital · 71d
Cleared Jan 19, 1996
MEDCARE YANKAUER SUCTION DEVICE
K954869 · GCX
Medcare Custom Packaging, Inc.
General Hospital · 87d
Cleared Jan 18, 1996
ABBOTT XL3M INFUSION PUMP
K952799 · FRN
Abbott Laboratories
General Hospital · 213d
Cleared Jan 18, 1996
HOSPITEC MEDI-BUTLER
K954500 · FMI
Hospitec, Inc.
General Hospital · 112d
Cleared Jan 11, 1996
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
K954766 · FNM
Span-America Medical Systems, Inc.
General Hospital · 86d
Cleared Jan 04, 1996
PATIENT EXAMINATION GLOVES
K953462 · LYY
P.T. Irama Dinamika Latex
General Hospital · 164d
Cleared Jan 04, 1996
STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS
K954720 · LJS
Strato/Infusaid, Inc.
General Hospital · 83d
Cleared Jan 04, 1996
NIPRO SCALP VEIN SET (DISPOSABL PSV SET)
K955053 · FOZ
Nissho Corp.
General Hospital · 59d
Cleared Jan 02, 1996
PACIFIER THERMOMETER
K952541 · FLL
Regitar U.S.A., Inc.
General Hospital · 249d
Cleared Dec 29, 1995
DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A
K955142 · FLL
Salutron, Inc.
General Hospital · 46d
Cleared Dec 28, 1995
POP-N-LOK SYRINGE
K946219 · MEG
Retractable Technologies, Inc.
General Hospital · 372d
Cleared Dec 28, 1995
FOAM INSTRUMENT GUARD
K952787 · KCT
Oxboro Medical Intl., Inc.
General Hospital · 192d
Cleared Dec 28, 1995
SURGEONS GLOVE POWDER FREE
K953358 · KGO
American Pro Latex, Inc.
General Hospital · 164d
Cleared Dec 28, 1995
ULTRAFIT LINERS
K954314 · LYU
Stahmer Weston Scientific
General Hospital · 104d
Cleared Dec 28, 1995
POWDER FREE PLUS PATIENT EXAMINATION GLOVE
K954855 · LYY
Tillotson Healthcare Corp.
General Hospital · 66d
Cleared Dec 22, 1995
FLEXIFLO 6.1 ENTERAL NUTRITION PUMP
K951429 · LZH
Ross Products
General Hospital · 269d
Cleared Dec 22, 1995
VOLUMETRIC INFUSION PUMP
K953098 · FRN
Baxter Healthcare Corp
General Hospital · 172d
Cleared Dec 21, 1995
STERILE ISOTONIC SALINE & STERILE WATER
K954442 · JOL
Medcare Custom Packaging, Inc.
General Hospital · 87d
Cleared Dec 21, 1995
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES
K954573 · LZA
Tillotson Healthcare Corp.
General Hospital · 80d