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
124393–124416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1990
PRECISION OPTICS ENDOSCOPE ADAPTER
K903459 · FET
Precise Optics
Gastroenterology & Urology · 86d
Cleared Oct 26, 1990
DSL ERYTHROPOIETIN (DSL # 1100)
K903492 · GGT
Diagnostic Systems Laboratories, Inc.
Hematology · 84d
Cleared Oct 26, 1990
ILC LEG BAG HOLDER
K903611 · FAQ
Inman Liebelt Corp.
Gastroenterology & Urology · 78d
Cleared Oct 26, 1990
SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH
K903709 · GBZ
Lifestream Int'L, Inc.
General & Plastic Surgery · 71d
Cleared Oct 26, 1990
EZ-BEAD TSH ENZYME IMMUNOASSAY KIT
K903725 · JLW
Immunotech Corp.
Chemistry · 71d
Cleared Oct 26, 1990
CAT. #6000-21 VOLUME NECK COIL, MODIFIED
K903753 · LNH
Medical Advances, Inc.
Radiology · 94d
Cleared Oct 26, 1990
CAT. #4050-64 & 4065-64 SHOULDER COILS, MODIFIED
K903754 · LNH
Medical Advances, Inc.
Radiology · 94d
Cleared Oct 26, 1990
CAT/ #4100-21 SHOULDER COIL PACKAGE, MODIFIED
K903755 · LNH
Medical Advances, Inc.
Radiology · 94d
Cleared Oct 26, 1990
IRRICLEAR EAR IRRIGATION SYRINGE
K903759 · KYZ
Nortech Laboratories, Inc.
General Hospital · 67d
Cleared Oct 26, 1990
SUNGLASSES
K903902 · HQY
K & P Trading Co., Inc.
Ophthalmic · 64d
Cleared Oct 26, 1990
REPAK SURGICAL PACKS
K903908 · KKX
Repack Surgical Enterprises, Inc.
General Hospital · 64d
Cleared Oct 26, 1990
BLIND CONTROLS FOR DRUGS OF ABUSE TESTING
K903909 · DIF
Rapid Diagnostic Laboratories, Inc.
Toxicology · 65d
Cleared Oct 26, 1990
LUBRICATING JELLY
K903910 · KMJ
Lake Pharmaceutical, Inc.
General Hospital · 64d
Cleared Oct 26, 1990
SLT CONTACT LASER SYSTEM ND:YAG MEDICAL LASER SYST
K903936 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 60d
Cleared Oct 26, 1990
MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON
K904087 · CAW
Invacare Corp.
Anesthesiology · 52d
Cleared Oct 26, 1990
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS
K904099 · JJY
Hichem Diagnostics
Chemistry · 50d
Cleared Oct 26, 1990
SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS
K904221 · CAK
Baxter Healthcare Corp
General Hospital · 43d
Cleared Oct 26, 1990
SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS
K904223 · CAK
Baxter Healthcare Corp
General Hospital · 43d
Cleared Oct 26, 1990
RECEIVING BLANKET
K904274 · KME
Anago, Inc.
General Hospital · 38d
Cleared Oct 26, 1990
DUPONT DRUG CLIBRATOR-B
K904303 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 37d
Cleared Oct 26, 1990
DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD
K904304 · KLB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 37d
Cleared Oct 26, 1990
BIOCLONES ELEGANCE FSH ELISA KIT
K904405 · CGJ
Bioclone Australia Pty , Ltd.
Chemistry · 31d
Cleared Oct 26, 1990
METER TRAX
K904461 · JPK
Hematronix, Inc.
Chemistry · 25d
Cleared Oct 26, 1990
BAXTER SINGLE PATIENT USE PRESSURE INFUSOR
K904484 · KZD
Tecnadyne Scientific, Inc.
General Hospital · 24d