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: Cleared only ×
174,955 results
103753–103776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1995
ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
K942986 · HGI
Aaron Medical Industries
Obstetrics & Gynecology · 293d
Cleared Mar 21, 1995
KSEA SEMM TISSUR PUNCH
K943053 · HET
Karl Storz Endoskop GmbH
Obstetrics & Gynecology · 267d
Cleared Mar 21, 1995
STA SYSTEM CONTROL [N] + [P] KIT
K943518 · GGN
American Bioproducts Co.
Hematology · 243d
Cleared Mar 21, 1995
CHEM TRAK ACCUMETER
K943599 · CHH
Chemtrak, Inc.
Chemistry · 258d
Cleared Mar 21, 1995
3000 AEROSOL TWO
K943990 · CAF
Medical Industries America, Inc.
Anesthesiology · 217d
Cleared Mar 21, 1995
LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3
K944525 · JJY
Medical Analysis Systems, Inc.
Chemistry · 186d
Cleared Mar 21, 1995
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
K944698 · CFT
Organon Teknika Corp.
Chemistry · 179d
Cleared Mar 21, 1995
SIEMENS 1481 T TRANSMITTER, ENHANCED
K945037 · DRG
Siemens Medical Solutions USA, Inc.
Cardiovascular · 159d
Cleared Mar 21, 1995
PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM
K945261 · KPS
Ohio Imaging, Inc.
Radiology · 144d
Cleared Mar 21, 1995
STRATIS
K945386 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 138d
Cleared Mar 21, 1995
UD 150L-F
K945452 · IZO
Shimadzu Medical Systems
Radiology · 134d
Cleared Mar 21, 1995
UD 150L-R II
K945453 · IZO
Shimadzu Medical Systems
Radiology · 134d
Cleared Mar 21, 1995
SILICATH ALL SILICONE FOLEY CATHETER
K945806 · EZL
Unomedical Sdn Bhd
Gastroenterology & Urology · 113d
Cleared Mar 21, 1995
X-RAY FILM CASSETTE
K945858 · IXA
J.P.I. Chicago Co.
Radiology · 110d
Cleared Mar 21, 1995
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER
K945982 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 103d
Cleared Mar 21, 1995
URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD
K946116 · JIL
Chemtech Labs, Inc.
Chemistry · 96d
Cleared Mar 21, 1995
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
K950028 · LFT
Sigma Diagnostics, Inc.
Toxicology · 76d
Cleared Mar 21, 1995
SII 525 APR
K950040 · IZO
Scott Imaging Intl., Inc.
Radiology · 75d
Cleared Mar 21, 1995
SII 360 APR
K950041 · IZO
Scott Imaging Intl., Inc.
Radiology · 75d
Cleared Mar 21, 1995
RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR
K950101 · CBS
Marquette Electronics, Inc.
Anesthesiology · 69d
Cleared Mar 21, 1995
ELX800 AND EL800 AUTOMATED MICROPLATE READERS
K950104 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 69d
Cleared Mar 21, 1995
URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
K950134 · DLN
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 67d
Cleared Mar 21, 1995
URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
K950182 · DIW
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 63d
Cleared Mar 21, 1995
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
K950221 · JXA
Izon Business Products, Inc.
Chemistry · 61d