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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
132529–132552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1989
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
K885284 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 30, 1989
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
K885285 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 30, 1989
VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE
K885347 · BZT
Vitacomm, Inc.
Anesthesiology · 33d
Cleared Jan 30, 1989
MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
K890045 · DTB
Medtronic Vascular
Cardiovascular · 25d
Cleared Jan 27, 1989
UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.
K871115 · CIG
Labo Science-USA, Inc.
Chemistry · 680d
Cleared Jan 27, 1989
KARLSON OZONE STERILIZER MODEL 100B
K873200 · FLF
Life Enhancement Technologies, LLC
General Hospital · 533d
Cleared Jan 27, 1989
ATYPICAL CHOLINESTERASE
K873496 · DIH
Sclavo, Inc.
Chemistry · 528d
Cleared Jan 27, 1989
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
K880049 · DIH
Sclavo, Inc.
Chemistry · 387d
Cleared Jan 27, 1989
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
K880199 · DIH
Sclavo, Inc.
Chemistry · 380d
Cleared Jan 27, 1989
BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD
K883967 · JGJ
Beckman Instruments, Inc.
Chemistry · 129d
Cleared Jan 27, 1989
LEA PLAZA SPINAL FRAME SYSTEM
K884585 · KWP
Orthomet, Inc.
Orthopedic · 86d
Cleared Jan 27, 1989
HELIOMOLAR(R) DENTAL RESTORATIVE
K884588 · EBF
Williams Dental Co., Inc.
Dental · 86d
Cleared Jan 27, 1989
TECHNICON RA-100 SYSTEM CALCIUM METHOD
K884599 · CIC
Technicon Instruments Corp.
Chemistry · 85d
Cleared Jan 27, 1989
TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE
K884601 · CHJ
Technicon Instruments Corp.
Chemistry · 85d
Cleared Jan 27, 1989
RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET
K884696 · HDR
Laboratoire Ccd C/O Washington...
Obstetrics & Gynecology · 79d
Cleared Jan 27, 1989
ANALYST THYROXINE (T4) ROTOR
K884700 · KLI
The DU Pont Co.
Chemistry · 79d
Cleared Jan 27, 1989
EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629
K884702 · GFO
Em Diagnostic Systems, Inc.
Hematology · 79d
Cleared Jan 27, 1989
DANSU PERMANENT CHAIR SOFT LINER
K884751 · EBI
American Mfg., Inc.
Dental · 78d
Cleared Jan 27, 1989
LIPOCLEAR LIPEMIA CLEARING REAGENT
K884807 · JKA
Statspin Technologies
Chemistry · 71d
Cleared Jan 27, 1989
GAS TRAK PLUS
K884977 · JJY
United Diagnostics, Inc.
Chemistry · 58d
Cleared Jan 27, 1989
TARGET READER
K885254 · JQT
V-Tech, Inc.
Chemistry · 35d
Cleared Jan 27, 1989
MICROSURGICAL NEEDLE HOLDERS
K890211 · GDF
Kinetic Medical Products
General & Plastic Surgery · 9d
Cleared Jan 27, 1989
MICROSURGICAL SCISSORS
K890212 · HRR
Kinetic Medical Products
Orthopedic · 9d
Cleared Jan 27, 1989
MICROSURGICAL FORCEPS
K890213 · HTD
Kinetic Medical Products
General & Plastic Surgery · 9d