Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
150577–150600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1985
ALT/GPT REAGENT SET
K844251 · CKA
Sterling Biochemical, Inc.
Chemistry · 67d
Cleared Jan 08, 1985
DATA-CHEM MAGNESIUM
K844278 · JGJ
Data Medical Associates, Inc.
Chemistry · 64d
Cleared Jan 08, 1985
TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE
K844343 · FIE
Top Surgical Manufacturers Co.
Gastroenterology & Urology · 60d
Cleared Jan 08, 1985
RESPIRALEX LATEX AGGLUTINATION TEST
K844399 · GTZ
Orion Diagnostica, Inc.
Immunology · 56d
Cleared Jan 08, 1985
DERMIDRESS
K844463 · KGX
Kells Medical, Inc.
General & Plastic Surgery · 49d
Cleared Jan 08, 1985
BARD URETEROSCOPIC CYTOLOGY BRUSH
K844561 · FDX
C.R. Bard, Inc.
Gastroenterology & Urology · 48d
Cleared Jan 08, 1985
ELECTROCAINE MODEL SR-IV
K844638 · GZJ
Electrocaine Medical System
Neurology · 41d
Cleared Jan 08, 1985
COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM
K844684 · KNX
Coloplast A/S
Gastroenterology & Urology · 39d
Cleared Jan 08, 1985
COLOPLAST URO 2002 UROSTOMY SYSTEM
K844685 · EXB
Coloplast A/S
Gastroenterology & Urology · 39d
Cleared Jan 08, 1985
CRITIC-ARS
K844709 · JIX
Dimension Diagnostics
Chemistry · 36d
Cleared Jan 08, 1985
INNOFLUOR PRIMIDONE
K844721 · LKT
Innotron Diagnostics
Toxicology · 35d
Cleared Jan 08, 1985
FOCUS UREA NITROGEN
K844755 · CDQ
Abbott Laboratories
Chemistry · 33d
Cleared Jan 08, 1985
UROL-QUAL
K844760 · JJY
Dimension Diagnostics
Chemistry · 32d
Cleared Jan 08, 1985
EFF-EFFNER BULBS
K844773 · FFS
Mecron Medical Products, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 08, 1985
MODIFY ELECTROLYTE ANALYZER MODEL SERA-210
K844806 · CEM
Horiba Instruments, Inc.
Chemistry · 28d
Cleared Jan 07, 1985
GLB VARICELLA-ZOSTER VIRUS FLUORESCENT
K842096 · GQX
Great Lakes Bioscience
Microbiology · 227d
Cleared Jan 07, 1985
COULTER MEAN PLATELET VOLUME CALIBRATOR
K843910 · KRY
Coulter Electronics, Inc.
Hematology · 96d
Cleared Jan 07, 1985
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
K843963 · FKQ
Renal Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 07, 1985
RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
K844108 · FKX
Renal Systems, Inc.
Gastroenterology & Urology · 76d
Cleared Jan 07, 1985
CONCISE LIGHT CURED WHITE SEALANT
K844211 · EBC
3M Company
Dental · 68d
Cleared Jan 07, 1985
ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII
K844287 · GLZ
Apple Diagnostic Products
Microbiology · 63d
Cleared Jan 07, 1985
NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS
K844391 · DXH
Ams Medical, Inc.
Cardiovascular · 55d
Cleared Jan 07, 1985
ALBUMIN BCP
K844426 · CJW
Boehringer Mannheim Corp.
Immunology · 53d
Cleared Jan 07, 1985
V AGAR
K844513 · JSH
bioMerieux, Inc.
Microbiology · 47d