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
89833–89856 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1998
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
K981423 · JEC
Autogenesis, Inc.
Orthopedic · 30d
Cleared May 20, 1998
OSTEONICS LONG ARM CONTAINMENT RING
K981452 · KWP
Osteonics Corp.
Orthopedic · 28d
Cleared May 20, 1998
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND...
K981458 · EOB
Karl Storz Endoscopy
Ear, Nose, Throat · 27d
Cleared May 20, 1998
CUB DIS II DPOAE MEASUREMENT SYSTEM
K981460 · EWO
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 27d
Cleared May 19, 1998
CRISTOBAL
K980018 · EBF
Newave Medical, Inc.
Dental · 137d
Cleared May 19, 1998
CATARACT LIQUEFRACTURE DEVICE
K980292 · MUS
Alcon Laboratories
Ophthalmic · 113d
Cleared May 19, 1998
OPHTHAVISION IMAGING SYSTEM
K980295 · HKI
Mrp Group, Inc.
Ophthalmic · 112d
Cleared May 19, 1998
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
K980604 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 91d
Cleared May 19, 1998
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
K980625 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d
Cleared May 19, 1998
PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236
K980656 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared May 19, 1998
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared May 19, 1998
PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
K980797 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 78d
Cleared May 19, 1998
SOVEREIGN CATARACT EXTRACTION SYSTEM
K981116 · KYG
Allergan, Inc.
Ophthalmic · 53d
Cleared May 19, 1998
RONDEX CPR ISO-SHIELD
K981169 · CBP
Rondex Products, Inc.
Anesthesiology · 50d
Cleared May 18, 1998
VAPOCIDE
K970726 · MED
Cottrell, Ltd.
General Hospital · 444d
Cleared May 18, 1998
OLYMPUS SONOSURG SYSTEM
K972114 · LFL
The Olympus Optical Co.
General & Plastic Surgery · 347d
Cleared May 18, 1998
NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR...
K973789 · GXP
Norian Corp.
Neurology · 224d
Cleared May 18, 1998
RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)
K973892 · KNT
Rusch Intl.
Gastroenterology & Urology · 216d
Cleared May 18, 1998
ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE...
K974015 · FOZ
Davis & Geck, Inc.
General Hospital · 208d
Cleared May 18, 1998
CRITIKON SOFT BLOOD PRESSURE CUFF
K974080 · DXQ
Johnson & Johnson Medical, Inc.
Cardiovascular · 201d
Cleared May 18, 1998
MICRO-PLATE COTININE EIA
K974534 · MKU
OraSure Technologies, Inc.
Toxicology · 167d
Cleared May 18, 1998
CRYPTOSPORIDIUM TEST
K980354 · MHJ
Techlab, Inc.
Microbiology · 109d
Cleared May 18, 1998
PROWESS PRO-SIM
K980379 · IYE
Ssgi Prowess Systems
Radiology · 108d
Cleared May 18, 1998
ATLASPLAN
K980584 · HAW
Radionics, Inc.
Neurology · 90d