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
136777–136800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1988
STERNUM SPREADER, PEDIATRIC
K880998 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 13d
Cleared Mar 21, 1988
KERATINOCYTE GROWTH MEDIUM (KGM)
K881000 · KIT
Clonetics Corp.
Pathology · 13d
Cleared Mar 21, 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 10d
Cleared Mar 21, 1988
SAFETY PLUS MODEL 501
K881051 · IOR
Safety Rehab Systems, Inc.
Physical Medicine · 10d
Cleared Mar 21, 1988
TITANIUM FEMORAL HIP
K881128 · JDI
Depuy, Inc.
Orthopedic · 5d
Cleared Mar 18, 1988
PC POLYGRAF
K872712 · KLA
Synectics-Dantec
Gastroenterology & Urology · 252d
Cleared Mar 18, 1988
BOND FAST NO MIX ADHESIVE
K874228 · DYH
Advanced Orthodontics Systems, Inc.
Dental · 154d
Cleared Mar 18, 1988
JEL-62
K874308 · EJT
Jelenko Co.
Dental · 150d
Cleared Mar 18, 1988
PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER
K874458 · EMA
Lustgarten Multi-Tech International,...
Dental · 141d
Cleared Mar 18, 1988
QUIDEL TOTAL IGE TEST
K875168 · DHB
Quidel Corp.
Immunology · 93d
Cleared Mar 18, 1988
DREAM DAM
K875255 · EIE
Dental Dam, Inc.
Dental · 87d
Cleared Mar 18, 1988
HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY
K875344 · EJJ
Kulzer, Inc.
Dental · 79d
Cleared Mar 18, 1988
DEN-MAT PORETCH (PORCELAIN ETCHANT)
K875351 · ELL
Den-Mat Corp.
Dental · 78d
Cleared Mar 18, 1988
CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7
K880333 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 52d
Cleared Mar 18, 1988
CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7
K880334 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 52d
Cleared Mar 18, 1988
INTRA II SECRET EAR HEARING AIDS ISE
K880335 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 52d
Cleared Mar 18, 1988
SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH
K880482 · FPA
Baxter Healthcare Corp
General Hospital · 42d
Cleared Mar 18, 1988
CLP 0.02 M CALCIUM CHLORIDE SOLUTION.
K880711 · GIT
Creative Laboratory Products, Inc.
Hematology · 25d
Cleared Mar 18, 1988
CLP 0.1 M SODIUM CITRATE SOLUTION
K880713 · JPA
Creative Laboratory Products, Inc.
Hematology · 25d
Cleared Mar 17, 1988
OPTEC 1000 DMV VISION TESTER MODIFY
K875237 · HOX
Stereo Optical Co., Inc.
Ophthalmic · 86d
Cleared Mar 17, 1988
TOXO IGM TEST
K880007 · GLZ
Gull Laboratories, Inc.
Microbiology · 73d
Cleared Mar 17, 1988
3 IN 1 AUTOMATIC TOURNIQUET
K880020 · KCY
Systematics Mfg. & Tool Co., Inc.
General & Plastic Surgery · 72d
Cleared Mar 17, 1988
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS
K880031 · LJP
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 72d
Cleared Mar 17, 1988
THE STORZ BIPOLAR PENCIL AND CORD
K880293 · GXI
Storz Instrument Co.
Neurology · 52d