FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

Filters: Cleared only ×
175,820 results
129193–129216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1989
HI CHEM CALIBRATOR A+
K895135 · JIX
Hichem Diagnostics
Chemistry · 68d
Cleared Oct 23, 1989
FORTRESS 1000FS ADD-ON POWER UNIT
K895596 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 38d
Cleared Oct 23, 1989
URIC ACID PAP
K895665 · KNK
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Oct 20, 1989
MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES
K882270 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 507d
Cleared Oct 20, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891301 · LYY
Taiping Leasing Corp. Sdn. Bhd.
General Hospital · 221d
Cleared Oct 20, 1989
SW 803 LOW FREQUENCY STIMULATOR DANA TOUCH
K891458 · IPF
Back IN Action, Inc.
Physical Medicine · 219d
Cleared Oct 20, 1989
IMPLA-MED IMPLANT SYSTEM
K892124 · DZE
Impla-Med
Dental · 199d
Cleared Oct 20, 1989
HEATED SERVO HUMIDIFIER, MODEL HDS 2
K893122 · BTT
Lifetronics, Inc.
Anesthesiology · 178d
Cleared Oct 20, 1989
SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR
K894630 · DTZ
Shiley, Inc.
Cardiovascular · 88d
Cleared Oct 20, 1989
SKYROCK AND LIGHT SUPERBOND
K894639 · DYH
Dent Zar, Inc.
Dental · 88d
Cleared Oct 20, 1989
CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST
K894644 · EBF
Jeneric/Pentron, Inc.
Dental · 88d
Cleared Oct 20, 1989
KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS
K894658 · JWH
Howmedica Corp.
Orthopedic · 88d
Cleared Oct 20, 1989
MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K894668 · CAC
Shiley, Inc.
Anesthesiology · 87d
Cleared Oct 20, 1989
CYPRESS MEDICAL BONE SCREW & PLATES
K894719 · HWC
Cypress Medical Mfg., Inc.
Orthopedic · 88d
Cleared Oct 20, 1989
TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE
K894721 · DWE
The Traumafuse Co.
Cardiovascular · 87d
Cleared Oct 20, 1989
ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS
K895263 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 58d
Cleared Oct 20, 1989
MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT
K895348 · GEX
Lasag Medical Lasers
General & Plastic Surgery · 49d
Cleared Oct 20, 1989
REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER
K895409 · LEJ
Remington Products Company, LLC
General & Plastic Surgery · 44d
Cleared Oct 20, 1989
MODIFIED ENDOGUIDE
K895559 · GEX
Luxar Corp.
General & Plastic Surgery · 49d
Cleared Oct 20, 1989
PRIMIDONE (FPIA) KIT
K895567 · LFT
Tudor Laboratories, Inc.
Toxicology · 44d
Cleared Oct 20, 1989
SILICONE INSTRUMENT SHODS
K895591 · GDJ
Key Surgical, Inc.
General & Plastic Surgery · 35d
Cleared Oct 19, 1989
ELECTRO-TOUCH (ET) GLOVE
K890981 · GXY
Psychoenergetic Systems, Inc.
Neurology · 234d
Cleared Oct 19, 1989
BIOLOX CERAMIC BALL
K892644 · LZO
Allo Pro Corp.
Orthopedic · 190d
Cleared Oct 19, 1989
MIP/CT IMAGE PROCESSING WORKSTATION
K892712 · LLZ
Kontron Electronics
Radiology · 188d