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
7369–7392 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 08, 2002
RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
K011238 · LZF
Metracor Technologies, Inc.
General Hospital · 260d
Cleared Jan 08, 2002
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
K013589 · LYY
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 70d
Cleared Jan 08, 2002
BOEHRINGER MRI SUCTION REGULATORY
K013976 · KDP
Boehringer Laboratories
General Hospital · 36d
Cleared Jan 07, 2002
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
K013523 · LHI
Shire Biologics, Inc.
General Hospital · 76d
Cleared Dec 31, 2001
REMEDY MODEL 2Z12
K012029 · KMG
Apollo Corp.
General Hospital · 186d
Cleared Dec 31, 2001
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
K013556 · FOZ
Tyco Healthcare
General Hospital · 67d
Cleared Dec 31, 2001
POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)
K013942 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 32d
Cleared Dec 31, 2001
STRYKER PAINPUMP
K014091 · FRN
Stryker Corp.
General Hospital · 19d
Cleared Dec 21, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO,...
K013800 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 36d
Cleared Dec 20, 2001
FILTERFLO H
K011212 · CAH
Arc Medical, Inc.
General Hospital · 244d
Cleared Dec 19, 2001
DIGICAP
K012199 · GAB
Humana USA, Inc.
General Hospital · 159d
Cleared Dec 19, 2001
BLUE LATEX EXAMINATION GLOVES, POWDER FREE
K013320 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 75d
Cleared Dec 17, 2001
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE...
K013302 · KGO
Allegiance Healthcare Corp.
General Hospital · 75d
Cleared Dec 17, 2001
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K013317 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 74d
Cleared Dec 14, 2001
RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01
K013200 · CAH
Rennels Medical Corp.
General Hospital · 80d
Cleared Dec 14, 2001
NIPRO HYPODERMIC NEEDLE
K013293 · FMI
Nipro Medical Corp.
General Hospital · 73d
Cleared Dec 13, 2001
ULTRASAFE DENTAL INJECTION SYSTEM
K013801 · MEG
Safety Syringes, Inc.
General Hospital · 28d
Cleared Dec 12, 2001
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN,...
K013767 · FRN
Sterling Medivations, Inc.
General Hospital · 29d
Cleared Dec 12, 2001
MICROJET QUARK, MODEL U100 OR U40
K013807 · LZG
Cane S.R.L.
General Hospital · 27d
Cleared Dec 11, 2001
H.M.T. ACUPUNCTURE NEEDLE
K012501 · MQX
Hummingbird Medical Technology, LLC
General Hospital · 130d
Cleared Dec 11, 2001
ACUGLIDE BRAND ACUPUNCTURE NEEDLES
K012583 · MQX
Helio Medical Supplies, Inc.
General Hospital · 123d
Cleared Dec 10, 2001
Z-NET
K001003 · FMW
Demite Limited
General Hospital · 621d
Cleared Dec 10, 2001
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K013753 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 27d
Cleared Dec 07, 2001
MASTER & FRANK SURGICAL GOWNS (STERILE)
K012186 · FYA
Master & Frank Ent. Co., Ltd.
General Hospital · 148d