FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
89329–89352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 18, 1998
SEGMENTAL DEFECT REPLACEMENT SYSTEM
K980609 · HSB
Metagen, LLC
Orthopedic · 90d
Cleared May 18, 1998
DEXON RAPID (DEXON R)
K980610 · GAM
Davis & Geck, Inc.
General & Plastic Surgery · 90d
Cleared May 18, 1998
CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING...
K980754 · LYY
Crocker Industrial Resources Sdn. Bhd.
General Hospital · 81d
Cleared May 18, 1998
ETEST GREPAFLOXACIN
K980773 · JWY
Ab Biodisk
Microbiology · 77d
Cleared May 18, 1998
PASCO MIC AND MIC/ID PANELS
K980955 · JTN
Pasco Laboratories, Inc.
Microbiology · 66d
Cleared May 18, 1998
ORION VESTA DENTAL ALLOY
K981001 · EJS
European Dental Imports, Inc.
Dental · 61d
Cleared May 18, 1998
ORION WX DENTAL ALLOY
K981002 · EJS
European Dental Imports, Inc.
Dental · 61d
Cleared May 18, 1998
ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
K981020 · MID
Zeus Scientific, Inc.
Immunology · 60d
Cleared May 18, 1998
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
K981085 · FIP
Gambro Healthcare
Gastroenterology & Urology · 54d