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
109225–109248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1994
EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30
K940073 · FPA
Puritas Health Care, Inc.
General Hospital · 76d
Cleared Mar 23, 1994
BIOSHIELD BLUE POWDER FREE GLOVE
K940254 · LYY
Chester Labs, Inc.
General Hospital · 61d
Cleared Mar 23, 1994
BIOSHIELD BLUE LATEX GLOVES
K940256 · LYY
Chester Labs, Inc.
General Hospital · 61d
Cleared Mar 23, 1994
X-LARGE MULTI-FUNCTION TRAUMA DRESSING
K940358 · EFQ
Certified Safety Mfg., Inc.
General & Plastic Surgery · 57d
Cleared Mar 23, 1994
ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE
K940480 · HTJ
Acufex Microsurgical, Inc.
Orthopedic · 49d
Cleared Mar 22, 1994
PRESSURE TUBING AND ACCESSORIES
K922777 · HIF
Arbor Technologies, Inc.
Obstetrics & Gynecology · 651d
Cleared Mar 22, 1994
INSUFFLATION TUBING
K924481 · HIF
Applied Medical Resources
Obstetrics & Gynecology · 565d
Cleared Mar 22, 1994
L CATH(R) CATHETER SYSTEM
K925236 · LJS
Luther Medical Products, Inc.
General Hospital · 522d
Cleared Mar 22, 1994
BONE CEMENT RESTRICTOR
K926216 · JDK
Biodynamic Technologies, Inc.
Orthopedic · 467d
Cleared Mar 22, 1994
STANDARD NEBULIZER HEATER
K926280 · CAF
Professional Medical Products, Inc.
Anesthesiology · 463d
Cleared Mar 22, 1994
EXERCISE BICYCLE
K926287 · ISD
Henley Intl.
Physical Medicine · 463d
Cleared Mar 22, 1994
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
K930267 · GGC
Biomerieux Vitek, Inc.
Hematology · 427d
Cleared Mar 22, 1994
CADWELL EASY WRITER AND EASY READER
K932407 · GWQ
Cadwell Laboratories, Inc.
Neurology · 308d
Cleared Mar 22, 1994
ACUFEX MENISCAL RASPS
K932460 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 305d
Cleared Mar 22, 1994
SIMULIX-MC CT EXTENSION
K932848 · JAK
Oldelft Corp. of America
Radiology · 285d
Cleared Mar 22, 1994
COAGULATION A.R.P.
K933277 · GGN
Helena Laboratories
Hematology · 264d
Cleared Mar 22, 1994
LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
K933804 · GYB
Cadwell Laboratories, Inc.
Neurology · 230d
Cleared Mar 22, 1994
N-ASSAY TIA IGM
K933970 · CFN
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Mar 22, 1994
N-ASSAY TIA IGA
K933971 · CFN
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Mar 22, 1994
N-ASSAY TIA IGG
K933972 · CFF
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Mar 22, 1994
DYNABITE HYSTEROSCOPIC FORCEPS
K934506 · HET
Portlyn Corp.
Obstetrics & Gynecology · 189d
Cleared Mar 22, 1994
ACE HUMERAL NAIL
K934643 · HSB
Ace Orthopedic Manufacturing Co.
Orthopedic · 174d
Cleared Mar 22, 1994
VIDAS T3 ASSAY
K934764 · CDP
Biomerieux Vitek, Inc.
Chemistry · 169d
Cleared Mar 22, 1994
THEREX LOW-PROFILE PORT
K934792 · LJT
Therex Corp.
General Hospital · 167d