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
126577–126600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1990
SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX
K901321 · LDQ
Sharp Safe, Inc.
General & Plastic Surgery · 51d
Cleared May 11, 1990
KLEIN CORK(TM)
K901715 · GCE
Jeff Klein Surgical, Inc.
General & Plastic Surgery · 28d
Cleared May 11, 1990
KLEIN CONNECTOR(TM)
K901716 · GCE
Jeff Klein Surgical, Inc.
General & Plastic Surgery · 28d
Cleared May 10, 1990
ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG
K896314 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 190d
Cleared May 10, 1990
IONTOPHORESIS DEVICE - ELECTRODE RH 800
K896444 · EGJ
Iomed, Inc.
Physical Medicine · 182d
Cleared May 10, 1990
SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM
K897118 · LDP
Medisense, Inc.
Toxicology · 135d
Cleared May 10, 1990
OLYMPUS(TM) TOTAL BILIRUBIN
K897174 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 134d
Cleared May 10, 1990
STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
K900797 · DXS
Shiley, Inc.
Cardiovascular · 79d
Cleared May 10, 1990
SOFT-WEDGE(TM) SYRINGE
K900879 · DYG
Baxter Healthcare Corp
Cardiovascular · 73d
Cleared May 10, 1990
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
K901123 · CDQ
Technicon Instruments Corp.
Chemistry · 59d
Cleared May 10, 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050
K901345 · CGJ
Medix Biotech, Inc.
Chemistry · 49d
Cleared May 10, 1990
MPR-4A - MICRO-PLATE READER
K901965 · JJQ
Tosoh Corp.
Chemistry · 10d
Cleared May 09, 1990
OXYTRAK(TM) PULSE OXIMETER
K894100 · DQA
Critikon Company, LLC
Anesthesiology · 334d
Cleared May 09, 1990
HTO COMPRESSING STAPLE
K895117 · JDR
Howmedica Corp.
Orthopedic · 267d
Cleared May 09, 1990
BURRON AMBULATORY DRUG DELIVERY SYSTEM
K896422 · FRN
Burron Medical, Inc.
General Hospital · 182d
Cleared May 09, 1990
DUALYSE-CATH - CODES #1132.212, 1132.112
K896568 · LFJ
Vygon Corp.
Gastroenterology & Urology · 170d
Cleared May 09, 1990
MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT
K900193 · OXO
Imt America, Inc.
Radiology · 113d
Cleared May 09, 1990
MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.
K900551 · DRS
Matrix Medica, Inc.
Cardiovascular · 92d
Cleared May 09, 1990
MODULAR HIP SYSTEM
K900628 · LZO
Richards Medical Co., Inc.
Orthopedic · 90d
Cleared May 09, 1990
UNIVERSAL DELIVERY SYSTEM CATHETER
K900657 · DQY
Microvena Corp.
Cardiovascular · 89d
Cleared May 09, 1990
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
K900815 · DTW
3M Company
Cardiovascular · 77d
Cleared May 09, 1990
MODIFIED PERM-CATH
K900835 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 76d
Cleared May 09, 1990
LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING
K900945 · KKX
Palex Medical, Inc.
General Hospital · 70d
Cleared May 09, 1990
MODIFIED ALPHA MC-9R C-ARM
K900967 · OXO
Instrumentarium Imaging, Inc.
Radiology · 68d