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
96121–96144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1996
IDS RAPID CB PLUS SYSTEM
K962966 · JTO
Innovative Diagnostic Systems, Inc.
Microbiology · 70d
Cleared Oct 08, 1996
ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980)
K963123 · GEI
Arthrocare Corp.
General & Plastic Surgery · 57d
Cleared Oct 08, 1996
SYNTHETIC ABSORBABLE SURGICAL SUTURE
K963253 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 50d
Cleared Oct 08, 1996
SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL
K963455 · KID
Skil-Care Corp.
Physical Medicine · 35d
Cleared Oct 08, 1996
LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER
K963456 · FMQ
Skil-Care Corp.
General Hospital · 35d
Cleared Oct 08, 1996
MIRROR FINISH BIPOLAR FORCEPS
K963499 · GEI
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 35d
Cleared Oct 08, 1996
A-1000 EEG MONITOR AND A-1050 EEG MONITOR
K963644 · OLW
Aspect Medical Systems, Inc.
Neurology · 26d
Cleared Oct 08, 1996
CCA-100 (MODIFIED)
K963681 · EWO
Benson Medical Instruments Co.
Ear, Nose, Throat · 89d
Cleared Oct 07, 1996
VIDAS CHLAMYDIA BLOCKING ASSAY
K955627 · LJC
Biomerieux Vitek, Inc.
Microbiology · 301d
Cleared Oct 07, 1996
LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION)
K961415 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 186d
Cleared Oct 07, 1996
LATEX PATIENT EXAMINATION GLOVE (PINK)
K961602 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 186d
Cleared Oct 07, 1996
EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
K962146 · GTZ
Excel Scientific, Inc.
Microbiology · 126d
Cleared Oct 07, 1996
2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD
K962286 · FXX
Berkley Medical Resources, Inc.
General Hospital · 115d
Cleared Oct 07, 1996
ONTRAK TESTCUP AMPHETAMINES
K962411 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 108d
Cleared Oct 07, 1996
ANGLED ABUTMENT
K962647 · DZE
Straumann USA
Dental · 91d
Cleared Oct 07, 1996
CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR
K962667 · DTZ
Terumo Medical Corp.
Cardiovascular · 90d
Cleared Oct 07, 1996
SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV....
K962709 · FRN
Sigma Intl.
General Hospital · 87d
Cleared Oct 07, 1996
T.B.Q.
K962739 · LRJ
Convatec, A Division of E.R. Squibb &...
General Hospital · 84d
Cleared Oct 07, 1996
2000 MODULAR THIRTY-NINE
K962763 · FNL
Equi-Tron Mfg., Inc.
General Hospital · 83d
Cleared Oct 07, 1996
GLUMA DESENSITIZER/GLUMA 3 PRIMER
K962812 · KLE
Heraeus Kulzer, Inc.
Dental · 81d
Cleared Oct 07, 1996
CATHETER INSERTION TRAY
K962849 · LJS
Medcare Medical Group, Inc.
General Hospital · 77d
Cleared Oct 07, 1996
DENTAL PREP WASH AND PREP DISINFECT
K962909 · EBF
William J. Day
Dental · 74d
Cleared Oct 07, 1996
MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
K962956 · KZE
Medi-Ject Corp.
General Hospital · 69d
Cleared Oct 07, 1996
SURGICAL STAPLE MARKER DEVICE (MODIFY)
K963015 · GDW
Biopsys Medical, Inc.
General & Plastic Surgery · 74d