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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
71881–71904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2003
CI TKR/UKR
K031770 · HAW
Brainlab AG
Neurology · 64d
Cleared Aug 12, 2003
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
K032146 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 29d
Cleared Aug 12, 2003
CRYOCARE CS SURGICAL SYSTEM
K032333 · GEH
Endocare, Inc.
Radiology · 14d
Cleared Aug 12, 2003
ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL
K032367 · HSB
Zimmer, Inc.
Orthopedic · 11d
Cleared Aug 11, 2003
BOWIE-DICK MINI PAK, MODEL BD 115
K024293 · JOJ
Steritec Products, Inc.
General Hospital · 230d
Cleared Aug 11, 2003
MALLORY/HEAD TOTAL HIP SYSTEM
K030055 · LPH
Biomet, Inc.
Orthopedic · 217d
Cleared Aug 11, 2003
DEROYAL SURGICAL DRAPES BACKTABLE COVER
K030908 · KKX
Deroyal
General Hospital · 140d
Cleared Aug 11, 2003
LED HEADLIGHT
K031548 · FSR
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Aug 11, 2003
SOLID STATE LAMP [LED] HEADLIGHT
K031549 · FSR
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Aug 11, 2003
RAMSOFT PACS, MODEL 3.0
K031562 · LLZ
Ramsoft, Inc.
Radiology · 84d
Cleared Aug 11, 2003
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
K031636 · DSP
Datascope Corp.
Cardiovascular · 76d
Cleared Aug 11, 2003
ULTRASITE VALVE
K031923 · FPA
B.Braun Medical, Inc.
General Hospital · 49d
Cleared Aug 11, 2003
POLY Q (GARANT L, PENTA M, PENTA H)
K032001 · ELW
3M Espe AG Dental Products
Dental · 45d
Cleared Aug 11, 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Aug 11, 2003
CD HORIZON SPINAL SYSTEM
K032265 · KWQ
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Aug 08, 2003
VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1
K024359 · MYU
Vista Scientific, LLC
Neurology · 221d
Cleared Aug 08, 2003
ELECTROPHYSIOLOGY CATHETER
K030109 · NLH
Alliance Medical Corp.
Cardiovascular · 207d
Cleared Aug 08, 2003
HBS HEADLESS BONE SCREW
K030302 · HWC
Schoening & Assoc., Inc.
Orthopedic · 191d
Cleared Aug 08, 2003
OPUS SPINAL SYSTEM
K030369 · NKB
Howmedica Osteonics Corp.
Orthopedic · 185d
Cleared Aug 08, 2003
LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
K030529 · LZA
Jda (Tianjin) Plastic Rubber Co., Ltd.
General Hospital · 170d
Cleared Aug 08, 2003
IMMUNICON CELLSAVE PRESERVATIVE TUBE
K030596 · JKA
Immunicon Corp.
Chemistry · 164d
Cleared Aug 08, 2003
SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
K031428 · LXT
Synthes (Usa)
Orthopedic · 94d
Cleared Aug 08, 2003
RANDOX LIQUID PROTEIN CALIBRATOR
K031608 · JIX
Randox Laboratories, Ltd.
Chemistry · 78d
Cleared Aug 08, 2003
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
K031654 · GXR
Synthes (Usa)
Neurology · 72d