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
139465–139488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1987
AXIAL COMPRESSION SCREW
K870786 · KTT
Straub Clinic and Hospital
Orthopedic · 95d
Cleared Jun 01, 1987
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
K870831 · JPA
International Technidyne Corp.
Hematology · 90d
Cleared Jun 01, 1987
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
K870890 · CIN
Helena Laboratories
Chemistry · 88d
Cleared Jun 01, 1987
LASE SYSTEM II
K871334 · GEX
Lase, Inc.
General & Plastic Surgery · 59d
Cleared Jun 01, 1987
FETALERT ADR FETAL MONITOR
K871383 · HGM
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 55d
Cleared Jun 01, 1987
THEOPHYLLINE FPIA CALIBRATORS
K871394 · DLJ
Sigma Diagnostics, Inc.
Toxicology · 55d
Cleared Jun 01, 1987
STERILIZATION INDICATOR FOR FLASH STERILIZATION
K871672 · LRT
Propper Mfg. Co., Inc.
General Hospital · 34d
Cleared Jun 01, 1987
TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1
K871692 · LRQ
Automatic Liquid Packaging, Inc.
General & Plastic Surgery · 33d
Cleared Jun 01, 1987
ULTRAFLOW
K871901 · FZH
Custom Industries, Inc.
General & Plastic Surgery · 17d
Cleared Jun 01, 1987
SURGITEK DISPOSABLE BIPOLAR CORD
K871910 · GEI
Dermacare Products, Inc.
General & Plastic Surgery · 14d
Cleared Jun 01, 1987
MICRO SCISSOR, 1.7MM
K871923 · LRW
Arthropedics, Inc.
General & Plastic Surgery · 14d
Cleared Jun 01, 1987
STERILIZATION TRAY, TMJ INSTRUMENT SET
K871924 · FSM
Arthropedics, Inc.
General & Plastic Surgery · 14d
Cleared Jun 01, 1987
STRAIGHT CUP CURRETTE, 1.7MM
K871925 · FZS
Arthropedics, Inc.
General & Plastic Surgery · 14d
Cleared May 29, 1987
OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
K870235 · JDI
Osteonics Corp.
Orthopedic · 128d
Cleared May 29, 1987
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
K870807 · HNO
Allergan, Inc.
Ophthalmic · 91d
Cleared May 29, 1987
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
K870911 · CCC
American Bentley
Anesthesiology · 84d
Cleared May 29, 1987
SOLA UV GARD(TM) SUNGLASSES
K870997 · HQY
Sola-Syntex Ophthalmics
Ophthalmic · 79d
Cleared May 29, 1987
VASOTRAIN 447
K871107 · IRO
Henley Intl.
Physical Medicine · 71d
Cleared May 29, 1987
SIBIS REMOTE ACTUATOR
K871158 · HCB
Human Technologies, Inc.
Neurology · 66d
Cleared May 29, 1987
FLASHPAK CONTAINER SYSTEM
K871202 · FRG
Performance Instruments Corp.
General Hospital · 65d
Cleared May 29, 1987
TANTONE MULTI-DAY #633 TENS ELECTRODE
K871222 · GXY
Uni-Patch, Inc.
Neurology · 63d
Cleared May 29, 1987
HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H
K871236 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 63d
Cleared May 29, 1987
MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING
K871255 · FRO
Hercon Laboratories Corp.
General & Plastic Surgery · 59d
Cleared May 29, 1987
PERFORM DENTURE BASE RESIN
K871270 · EBF
Ipco Corp.
Dental · 59d