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
148153–148176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1985
MYOMETER EMG BIOFEEDBACK DEVICE
K850849 · HCC
Physio Technology, Inc.
Neurology · 91d
Cleared May 31, 1985
AXON II BRAND OF DUAL CHANNEL TENS
K850860 · GZJ
Cassandra Electronics Corp.
Neurology · 91d
Cleared May 31, 1985
CRESTLINE CB BEHIND-THE-EAR HEARING AID
K850981 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 81d
Cleared May 31, 1985
DELFIA HTSH KIT
K851120 · JLW
Lkb Instruments, Inc.
Chemistry · 73d
Cleared May 31, 1985
ELECTRO-NERVE STIMULATOR DISCO B9 TENS
K851191 · GZJ
Biomedical Life Systems, Inc.
Neurology · 91d
Cleared May 31, 1985
CILCO/UNITED SONICS PHACE PF-9000
K851209 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
UNITED SONICS PHACO MODULE, DF-35
K851210 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
UNITED SONICS PACO SYSTEM MODEL 3000
K851212 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
MID LABS MVSXI
K851298 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
OMNIMED CLAMP
K851654 · HXD
Omni Intl., Inc.
General & Plastic Surgery · 39d
Cleared May 31, 1985
COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY
K851942 · JJY
Coulter Electronics, Inc.
Chemistry · 28d
Cleared May 31, 1985
ENDAB TSH
K851980 · JLW
Immunotech Corp.
Chemistry · 24d
Cleared May 31, 1985
LD-L REAGENT
K851996 · CFJ
Alpkem Corp.
Chemistry · 24d
Cleared May 31, 1985
IP ACID REAGENT IP MOLY BDATE REAGENT
K852003 · CEO
Alpkem Corp.
Chemistry · 24d
Cleared May 31, 1985
SC-360 SPECTROPHOTOMETER
K852047 · JJQ
Pharmacia, Inc.
Chemistry · 22d
Cleared May 31, 1985
DIRECT BILIRUBEN CALIBRATIONS
K852067 · JIT
Data Medical Associates, Inc.
Chemistry · 21d
Cleared May 31, 1985
TOTAL BILIRUBIN STANDARDS
K852068 · JIS
Data Medical Associates, Inc.
Chemistry · 21d
Cleared May 31, 1985
INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN
K852103 · CEO
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared May 31, 1985
PORTASUN MODEL 600/LI SUNLAMP
K852149 · FTC
Portasun , Ltd.
General & Plastic Surgery · 14d
Cleared May 30, 1985
BORNING NEONATAL RESUSCITATOIN CENTER
K850069 · FMT
Borning Corp.
General Hospital · 147d
Cleared May 30, 1985
SPECTACLE FRAME
K851130 · HQZ
New Brillette A/S
Ophthalmic · 70d
Cleared May 30, 1985
SUNGLASES
K851163 · HQG
Full See Glasses Ind. Co., Ltd.
Ophthalmic · 69d
Cleared May 30, 1985
IV/0165 INFUSION SET
K851336 · FPA
Infarkem Corp.
General Hospital · 57d
Cleared May 30, 1985
ENTERAL FEEDING PUMP
K851351 · FRN
Empire Industries, Inc.
General Hospital · 56d