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
135409–135432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1988
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
K881437 · JJY
Hichem Diagnostics
Chemistry · 92d
Cleared Jul 06, 1988
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
K881438 · JJY
Hichem Diagnostics
Chemistry · 92d
Cleared Jul 06, 1988
SHILEY FEMORAL CORONARY PERFUSION CATHETER
K881733 · DWF
Shiley, Inc.
Cardiovascular · 75d
Cleared Jul 06, 1988
LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS
K882029 · JWY
Pasco Laboratories, Inc.
Microbiology · 65d
Cleared Jul 06, 1988
TDX (R) DIGOXIN NXT
K882233 · KXT
Abbott Laboratories
Chemistry · 40d
Cleared Jul 06, 1988
ACCU-CULSHURE TM
K882637 · JTX
Accu-Med Corp.
Microbiology · 9d
Cleared Jul 05, 1988
MODIFIED LABELING FOR TOXI-LAB THC SCREEN
K875182 · DKE
Marion Laboratories, Inc.
Toxicology · 201d
Cleared Jul 05, 1988
PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA
K881691 · DWF
Shiley, Inc.
Cardiovascular · 77d
Cleared Jul 05, 1988
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)
K881717 · DWS
Buckman Co., Inc.
Cardiovascular · 75d
Cleared Jul 05, 1988
SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER
K881734 · DWF
Shiley, Inc.
Cardiovascular · 74d
Cleared Jul 05, 1988
CONDOM
K881735 · HIS
Iris Medical Ent., Inc.
Obstetrics & Gynecology · 74d
Cleared Jul 05, 1988
ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.
K882104 · JGS
Paramax Systems Div. Baxter Healthcare
Chemistry · 47d
Cleared Jul 05, 1988
HEARING AID (ALL-IN-THE-EAR)
K882150 · ESD
Clear-Tone Hearing Aid Center
Ear, Nose, Throat · 43d
Cleared Jul 05, 1988
SPTL-1 PULSED DYE LASER
K882243 · GEX
Candela Laser Corp.
General & Plastic Surgery · 35d
Cleared Jul 05, 1988
PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER
K882409 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 25d
Cleared Jul 01, 1988
APOLLO CONDOM
K874236 · HIS
Apollo Enterprise, Ltd. Co.
Obstetrics & Gynecology · 260d
Cleared Jul 01, 1988
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200
K874910 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 213d
Cleared Jul 01, 1988
DIGITAL NUCLEAR IMAGING SYSTEM
K875198 · IYX
Medasys, Inc.
Radiology · 197d
Cleared Jul 01, 1988
DSL SOMATOMEDIN-C (DSL #5600)
K875229 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 192d
Cleared Jul 01, 1988
BIOPSY FIXATION UNIT-TYPE UA 0997
K875357 · IYO
Bruel & Kjaer Industri A/S
Radiology · 183d
Cleared Jul 01, 1988
G-MARK
K880076 · LIC
Bainbridge Laboratories, Inc.
Microbiology · 172d
Cleared Jul 01, 1988
UNI-PORT
K880543 · KYG
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 143d
Cleared Jul 01, 1988
ESPE VARNISH
K880741 · LBH
Espe GmbH (Us)
Dental · 128d
Cleared Jul 01, 1988
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
K880750 · JGS
Nova Biomedical Corp.
Chemistry · 128d