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
106825–106848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1994
HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3
K935599 · JJY
Clinical Controls, Inc.
Chemistry · 346d
Cleared Oct 31, 1994
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
K940979 · LSL
Gen-Probe, Inc.
Microbiology · 244d
Cleared Oct 31, 1994
ROCHE REAGENT
K941573 · CHH
Roche Diagnostic Systems, Inc.
Chemistry · 214d
Cleared Oct 31, 1994
IMMULITE SHBG
K941797 · CDZ
Diagnostic Products Corp.
Chemistry · 202d
Cleared Oct 31, 1994
AUDITORY CASSETTE
K941834 · KLW
Ltmlt, Inc.
Ear, Nose, Throat · 201d
Cleared Oct 31, 1994
PROTECTAIDE CPR PROTECTION PACK NO. 22100
K942468 · CBP
Protectaide, Inc.
Anesthesiology · 159d
Cleared Oct 31, 1994
PROTECTAIDE CPR PROTECTION PACK
K942469 · CBP
Protectaide, Inc.
Anesthesiology · 159d
Cleared Oct 31, 1994
DEPUY POROUS COATED GLOBAL SHOULDER
K943300 · KWS
Depuy, Inc.
Orthopedic · 115d
Cleared Oct 31, 1994
B-D SAFE-CLIP
K943683 · FMI
Becton Dickinson Consumer Products
General Hospital · 94d
Cleared Oct 31, 1994
FOLIC ACID
K943705 · CGN
Diagnostic Products Corp.
Chemistry · 91d
Cleared Oct 31, 1994
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000,...
K943780 · JJW
Heraeus Kulzer, Inc.
Chemistry · 89d
Cleared Oct 31, 1994
CARDIOCHEX CKMB MASS MEASUREMENT CONTROL
K944246 · JJT
Cala Diagnostics
Chemistry · 61d
Cleared Oct 31, 1994
CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL
K944247 · JJT
Cala Diagnostics
Chemistry · 61d
Cleared Oct 28, 1994
MATRX HOPE(R) 5 RESUSCITATOR
K921982 · BTM
Matrix Medica, Inc.
Anesthesiology · 913d
Cleared Oct 28, 1994
PM PUMP COMPRESSOR
K930509 · BTI
Precision Medical, Inc.
Anesthesiology · 634d
Cleared Oct 28, 1994
3P (PULMONARY PERCUSSIVE PACK)
K931988 · BYI
Delta Medical Manuf, Inc.
Anesthesiology · 554d
Cleared Oct 28, 1994
UNIVERSAL VIDEO/LASER ARM DRAPE
K934630 · KKX
Hydro-Med Products, Inc.
General Hospital · 399d
Cleared Oct 28, 1994
CAMERA COVER WITH TEAR TIP
K940152 · FEM
Hydro-Med Products, Inc.
Gastroenterology & Urology · 298d
Cleared Oct 28, 1994
CONTACT LENS
K941883 · HQD
Airperm, Inc.
Ophthalmic · 193d
Cleared Oct 28, 1994
PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS
K943874 · CAH
Precision Thermoplastic Components, Inc.
General Hospital · 81d
Cleared Oct 28, 1994
P2 NITRILE EXAM GLOVES
K944095 · LYY
Biosafety Systems, Inc.
General Hospital · 67d
Cleared Oct 28, 1994
P2 EXAM GLOVES
K944142 · LYY
Biosafety Systems, Inc.
General Hospital · 64d
Cleared Oct 28, 1994
TRANSPARENT ANESTHESIA FILTER
K944189 · CAH
Anetec, Inc.
General Hospital · 72d
Cleared Oct 28, 1994
MINI-OP LAPAROSCOPIC LASSO
K944784 · GEI
Uresil Corp.
General & Plastic Surgery · 31d