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
95473–95496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 1996
SPERM PREPARATION MEDIA
K962816 · MOL
Intl., Inc.
Obstetrics & Gynecology · 130d
Cleared Nov 26, 1996
BIOZ SYSTEM
K963183 · DSB
Cardiodynamics International Corp.
Cardiovascular · 104d
Cleared Nov 26, 1996
ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA...
K963189 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 104d
Cleared Nov 26, 1996
FLEX-LASE 600 SERIES ION LASER SYSTEM
K963389 · GEX
American Laser Medical
General & Plastic Surgery · 90d
Cleared Nov 26, 1996
NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200...
K963400 · DPS
Nellcor Puritan Bennett, Inc.
Cardiovascular · 89d
Cleared Nov 26, 1996
OXI TEMP
K963496 · DQA
Bci Intl., Inc.
Anesthesiology · 84d
Cleared Nov 26, 1996
APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM
K963510 · FNM
Mellen Air Mfg., Inc.
General Hospital · 84d
Cleared Nov 26, 1996
9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS
K963626 · FNM
9th Wave, Inc.
General Hospital · 76d
Cleared Nov 26, 1996
STRYKER SUCTION REGULATOR
K963648 · GCX
Stryker Endoscopy
General Hospital · 75d
Cleared Nov 26, 1996
9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD
K963677 · FNM
9th Wave, Inc.
General Hospital · 74d
Cleared Nov 26, 1996
MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE
K963704 · LYG
Shippert Medical Technologies Corp.
Physical Medicine · 71d
Cleared Nov 26, 1996
MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)
K963745 · ESD
Hearing Innovations, Inc.
Ear, Nose, Throat · 70d
Cleared Nov 26, 1996
IRRIGATION/SUCTION HANDLE AND SHEATH
K963757 · EOB
Richard Wolf Medical Instruments Corp.
Ear, Nose, Throat · 69d
Cleared Nov 26, 1996
STARKEY TM AIR CONDUCTION TINNITUS MASKER
K963838 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 63d
Cleared Nov 26, 1996
AHS OMEGA DEQ
K963873 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS OMEGA AGC
K963874 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS OMEGA PP
K963876 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS DELTA 22
K963879 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS DELTA 22 T
K963881 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER
K963995 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 53d
Cleared Nov 26, 1996
AUDIO 'D' SOUND SELECTOR POWER (SSP)
K964180 · ESD
Hearing Solutions, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 26, 1996
MENTOR TONO-PEN 3
K964312 · HKY
Mentor Ophthalmics, Inc.
Ophthalmic · 28d
Cleared Nov 26, 1996
PACIFIC 52 (CB-39)
K964464 · EJT
Gateway Alloys, Inc.
Dental · 19d
Cleared Nov 26, 1996
LA PLATA 34 (PM-25)
K964465 · EJT
Gateway Alloys, Inc.
Dental · 19d