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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
130273–130296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1989
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
K884927 · CAN
Instrumentation Industries, Inc.
Anesthesiology · 207d
Cleared Jun 23, 1989
BIO-MATE(TM) EPIDURAL CATHETER
K884969 · BSO
Medevice, Inc.
Anesthesiology · 205d
Cleared Jun 23, 1989
COI 72 HR COLLAGEN SHIELD
K885015 · MOE
Chiron Ophthalmics
Ophthalmic · 200d
Cleared Jun 23, 1989
THROMBOSTIN IFA*
K885107 · GJS
Investigacion Farmaceutica S.A. DE C.V.
Hematology · 193d
Cleared Jun 23, 1989
IMD 7GX
K885115 · EFB
Medical Dental Technology Co.
Dental · 193d
Cleared Jun 23, 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295 · LFX
Abbott Laboratories
Microbiology · 178d
Cleared Jun 23, 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297 · LFX
Abbott Laboratories
Microbiology · 178d
Cleared Jun 23, 1989
IMX TOXO IGG ANTIBODY ASSAY
K890031 · LGD
Abbott Laboratories
Microbiology · 170d
Cleared Jun 23, 1989
IMX TOXO IGM ANTIBODY ASSAY
K890032 · LGD
Abbott Laboratories
Microbiology · 170d
Cleared Jun 23, 1989
HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K890092 · LNH
Health Images, Inc.
Radiology · 164d
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