FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
88657–88680 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1998
INSTACINE D-2000
K983088 · LLZ
Fidelity Medical, Inc.
Radiology · 25d
Cleared Sep 22, 1998
MAGNATEK80
K983114 · CCK
Magna Advanced Technologies, Inc.
Anesthesiology · 18d
Cleared Sep 22, 1998
ELECSYS CALCHECK MYOGLOBIN
K983166 · JJY
Boehringer Mannheim Corp.
Chemistry · 12d
Cleared Sep 21, 1998
DIAMEDIX IS-CMV IGG TEST SYSTEM
K981163 · LFZ
Diamedix Corp.
Microbiology · 174d
Cleared Sep 21, 1998
UPRO
K981682 · JGQ
Abbott Laboratories
Chemistry · 131d
Cleared Sep 21, 1998
QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN...
K982152 · DIS
Phamatech
Toxicology · 95d
Cleared Sep 21, 1998
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K982394 · KLE
Dentsply Intl.
Dental · 74d
Cleared Sep 21, 1998
RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
K982767 · JIX
Raichem
Chemistry · 46d
Cleared Sep 18, 1998
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
K980816 · HQX
Fci Ophthalmics, Inc.
Ophthalmic · 199d
Cleared Sep 18, 1998
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
K981297 · LTK
Diagnostic Products Corp.
Immunology · 163d
Cleared Sep 18, 1998
KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR
K982176 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 88d
Cleared Sep 18, 1998
FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION...
K982182 · DXC
Radi Medical Systems AB
Cardiovascular · 88d
Cleared Sep 18, 1998
MANUAL RESUSCITATOR WITH ACE
K982215 · BTM
Medical Marketing Concepts
Anesthesiology · 87d
Cleared Sep 18, 1998
XOMED SILICONE PRE-FORM BLOCKS
K982294 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 80d
Cleared Sep 18, 1998
QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D
K982496 · MOS
Medical Advances, Inc.
Radiology · 63d
Cleared Sep 18, 1998
MTEK-1400
K982846 · CCK
Magna Advanced Technologies, Inc.
Anesthesiology · 37d
Cleared Sep 17, 1998
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS...
K973448 · LGD
Beckman Instruments, Inc.
Microbiology · 371d
Cleared Sep 17, 1998
PERCUSSIVETECH HF, MODEL 2001
K981726 · NHJ
Vortran Medical Technology 1, Inc.
Anesthesiology · 125d
Cleared Sep 17, 1998
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K982121 · DBM
Trace Scientific , Ltd.
Immunology · 93d
Cleared Sep 17, 1998
HAMAMATSU PET SCANNER, MODEL SHR-22000
K982171 · KPS
Hamamatsu Photonics K.K.
Radiology · 90d
Cleared Sep 17, 1998
TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER
K982179 · CAF
Trudell Medical
Anesthesiology · 87d
Cleared Sep 17, 1998
MTEK-1000
K982405 · DQA
Magna Advanced Technologies, Inc.
Anesthesiology · 69d
Cleared Sep 17, 1998
1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
K983003 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 20d
Cleared Sep 16, 1998
EUROMEDICAL HAEMATURIA FOLEY CATHETER
K973076 · EZL
Unomedical Sdn Bhd
Gastroenterology & Urology · 394d