FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
130873–130896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1989
GREER DERMAPIK SYSTEM
K890360 · SCL
Greer Laboratories, Inc.
General Hospital · 149d
Cleared Jun 23, 1989
ITEM #352/#CS352* CONTACT LENS CASES
K890533 · LRX
Magnivision, Inc.
Ophthalmic · 141d
Cleared Jun 23, 1989
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
K890610 · LFZ
Organon Teknika Corp.
Microbiology · 136d
Cleared Jun 23, 1989
MEDSURG EPIDURAL TRAY/19 GA/BUL TIP/17GA TUO 1002
K890731 · CAZ
Medsurg Industries, Inc.
Anesthesiology · 130d
Cleared Jun 23, 1989
MEDSURG EPIDURAL TRAY/BULLET TIP/17 GA TUOHY 1002E
K890732 · CAZ
Medsurg Industries, Inc.
Anesthesiology · 130d
Cleared Jun 23, 1989
MEDSURG EPIDURAL TRAY/19 GAGE OPEN END TUOHY 1012
K890733 · CAZ
Medsurg Industries, Inc.
Anesthesiology · 130d
Cleared Jun 23, 1989
GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)
K890782 · HMX
Grieshaber & Co.
Ophthalmic · 128d
Cleared Jun 23, 1989
PATIENT EXAMINATION GLOVE
K890931 · LYY
Phutex Products Co., Ltd.
General Hospital · 119d
Cleared Jun 23, 1989
SURFLO(R) WINGED INFUSION SET
K891063 · FPA
Terumo Medical Corp.
General Hospital · 114d
Cleared Jun 23, 1989
TERUMO SURFLO(R) I.V. CATHETER
K891087 · FOZ
Terumo Medical Corp.
General Hospital · 114d
Cleared Jun 23, 1989
TERUMO SURFLO(R) INJECTION PLUG
K891146 · FPA
Terumo Medical Corp.
General Hospital · 112d
Cleared Jun 23, 1989
SAMUELS - MICRO -SCLER CATHETER
K891164 · FPA
Polyval, Inc.
General Hospital · 109d
Cleared Jun 23, 1989
MARLOW ANAL SPECULUM
K891352 · KOA
Simpson/Basye, Inc.
Gastroenterology & Urology · 105d
Cleared Jun 23, 1989
ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT
K891393 · LFZ
Orgenics, Ltd.
Microbiology · 101d
Cleared Jun 23, 1989
NASOGASTRIC PH SUCTION CATHETER, ST-5001
K891410 · FFT
Sensatronix Medical Systems, Inc.
Gastroenterology & Urology · 101d
Cleared Jun 23, 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K891456 · JXG
Baxter Healthcare Corp
Neurology · 100d
Cleared Jun 23, 1989
MAGNAVIEW MOBILE MRI VERSION 110 FHM
K891543 · LNH
Instrumentarium Imaging, Inc.
Radiology · 98d
Cleared Jun 23, 1989
MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED
K891760 · LNH
Bruker Medical Imaging, Inc.
Radiology · 92d
Cleared Jun 23, 1989
VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED
K891771 · CAN
Thermadyne Holings Corp.
Anesthesiology · 91d
Cleared Jun 23, 1989
PS3500 ARTHROSCOPIC SURGICAL SYSTEM
K892062 · HRX
Dyonics, Inc.
Orthopedic · 85d
Cleared Jun 23, 1989
GENTLEHALER(R)
K892117 · CCQ
Schering Research
Anesthesiology · 84d
Cleared Jun 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892266 · LYY
Jenn Jiag Ent. Co., Ltd. C/O Rosyn...
General Hospital · 79d
Cleared Jun 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892289 · LYY
Ansell, Inc.
General Hospital · 78d
Cleared Jun 23, 1989
KALTOSTAT(TM) WOUND DRESSING
K892364 · FRO
Calgon Vestal Div.
General & Plastic Surgery · 78d