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
71281–71304 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 08, 2003
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K031702 · KWQ
Howmedica Osteonics
Orthopedic · 67d
Cleared Aug 08, 2003
OMNIFIT HFX HIP STEM SERIES
K031744 · JDI
Howmedica Osteonics Corp.
Orthopedic · 64d
Cleared Aug 08, 2003
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K031789 · ODG
Pentax Precision Instrument Corp.
Radiology · 59d
Cleared Aug 08, 2003
HANDMASTER
K031900 · GZI
Ness-Neuromuscular Electrical...
Neurology · 50d
Cleared Aug 08, 2003
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · MQE
Rocket Medical Plc
Radiology · 39d
Cleared Aug 08, 2003
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
K032017 · GGN
Bio-Rad
Hematology · 39d
Cleared Aug 08, 2003
PERIVAC KIT
K032050 · DQX
Boston Scientific Corp
Cardiovascular · 37d
Cleared Aug 08, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K032095 · JDK
Interpore Cross Intl.
Orthopedic · 31d