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
126217–126240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1990
CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE
K902336 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 25d
Cleared Jun 18, 1990
MODIFIED DELFIA ESTRADIOL KIT
K902358 · CHP
Pharmacia, Inc.
Chemistry · 20d
Cleared Jun 18, 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K902380 · KGO
Baxter Healthcare Corp
General Hospital · 19d
Cleared Jun 15, 1990
BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
K900546 · GTH
Baxter Healthcare Corp
Microbiology · 130d
Cleared Jun 15, 1990
WATER PIK(R) W/ADD'L CLAIMS
K900547 · EFS
Teledyne Water Pik
Dental · 130d
Cleared Jun 15, 1990
DOBBHOFF(R) POLYPECTOMY SNARE
K901322 · FDI
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 86d
Cleared Jun 15, 1990
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
K901414 · LCP
Helena Laboratories
Hematology · 81d
Cleared Jun 15, 1990
FORMASIL(R)A POLYVINYL SILOXANE LINE
K901681 · ELW
Kulzer, Inc.
Dental · 65d
Cleared Jun 15, 1990
SILISTOR CERAMIC AND RESIN REPAIR SYSTEM
K901697 · EBF
Kulzer, Inc.
Dental · 66d
Cleared Jun 15, 1990
ZEFAZONE SUSCEPTIBILITY TEST DISKS
K902082 · JTN
Difco Laboratories, Inc.
Microbiology · 38d
Cleared Jun 15, 1990
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
K902083 · GJT
Helena Laboratories
Hematology · 39d
Cleared Jun 14, 1990
DANEK PRECISION ROD SET
K896254 · KWP
Danek Medical, Inc.
Orthopedic · 227d
Cleared Jun 14, 1990
CARAGLAS XTRA SYNTHETIC CASTING TAPE
K896634 · LGF
Buckman Co., Inc.
Orthopedic · 204d
Cleared Jun 14, 1990
FRAME, SPECTACLE
K897091 · HQZ
Pt Midas Surya Optical Co.
Ophthalmic · 176d
Cleared Jun 14, 1990
EXPANDACEL NASAL TAMPONS
K900171 · EMX
Surgitrend, Ltd.
Ear, Nose, Throat · 153d
Cleared Jun 14, 1990
JAHN VENTILATION TUBE
K900267 · ETD
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 147d
Cleared Jun 14, 1990
BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT
K900518 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 132d
Cleared Jun 14, 1990
ARVEE APNEA MONITOR, MODEL 4800
K900730 · BZQ
Arvee Medical, Inc.
Anesthesiology · 119d
Cleared Jun 14, 1990
NUBALOO(R) SUNGLASSES
K901160 · HQY
Blublocker Corp.
Ophthalmic · 93d
Cleared Jun 14, 1990
(EYEGLASS) FRAMES AND SUNGLASSES
K901167 · HQY
Optique Marquis, Div. Sugerose, Inc.
Ophthalmic · 93d
Cleared Jun 14, 1990
INVOTEC BI-VALVE SPLINT
K901306 · LYA
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 14, 1990
PASSAGE AIRWAY SPLINT
K901307 · LYA
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 14, 1990
ULTRASTAT NASAL CATHETER
K901310 · EMX
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 14, 1990
INVOTEC SEPTAL BUTTON
K901366 · LFB
Invotec International, Inc.
Ear, Nose, Throat · 83d