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
154225–154248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1984
JAKOBI SURG. INSTRUMENTS #11 14/45
K834185 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 67d
Cleared Jan 27, 1984
JAKOBI SURG. INSTRUMENTS #11
K834186
Imm Enterprises , Ltd.
General & Plastic Surgery · 67d
Cleared Jan 27, 1984
JAKOBI SURG. INSTRUMENTS #1 19/10/26
K834194 · GES
Imm Enterprises , Ltd.
General & Plastic Surgery · 67d
Cleared Jan 27, 1984
JAKOBI SURG. INSTRUMENTS #11 11/13/14
K834195 · GES
Imm Enterprises , Ltd.
General & Plastic Surgery · 67d
Cleared Jan 27, 1984
JAKOBI SURG. INSTRUMENTS #11 20/25/27/37
K834196 · GAD
Imm Enterprises , Ltd.
General & Plastic Surgery · 67d
Cleared Jan 27, 1984
JAKOBI SURG. INSTR- #11 38/39/45/46/67
K834197 · EMF
Imm Enterprises , Ltd.
General & Plastic Surgery · 67d
Cleared Jan 27, 1984
JAKOBI SURG. INSTRUMENTS #12 40/41
K834198 · FZO
Imm Enterprises , Ltd.
General & Plastic Surgery · 67d
Cleared Jan 27, 1984
HYBRID PERIPHERAL DILATION CATHETER
K834220 · LIT
American Edwards Laboratories
Cardiovascular · 53d
Cleared Jan 27, 1984
PROPPER SERACULT
K834297 · KHE
Propper Mfg. Co., Inc.
Hematology · 50d
Cleared Jan 27, 1984
TSA
K834324 · JSG
Hardy Media
Microbiology · 49d
Cleared Jan 27, 1984
ADULT VENT CATHETER
K834352 · DRA
Dlp, Inc.
Cardiovascular · 45d
Cleared Jan 27, 1984
UVA SUNTANNING LAMPS
K834491 · FTC
D.P.R.M., Inc.
General & Plastic Surgery · 72d
Cleared Jan 27, 1984
ACETAMIDE AGAR SLANTS
K834509 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 37d
Cleared Jan 27, 1984
H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48
K834541 · GDX
Imm Enterprises , Ltd.
General & Plastic Surgery · 67d
Cleared Jan 27, 1984
H.R. JAKOBI SURG. INSTRU. SECT. 48
K834542 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 67d
Cleared Jan 27, 1984
IURA AMBULANCE STRETCHER IAS-1
K840122 · FPO
Trade West, Inc.
General Hospital · 16d
Cleared Jan 27, 1984
IURA UNIVERSAL HOSPITAL STRETCHER-HS-13
K840124 · FPO
Trade West, Inc.
General Hospital · 16d
Cleared Jan 27, 1984
IURA UNIVERSAL WHEELCHAIR/STRETCHER-
K840125 · FPO
Trade West, Inc.
General Hospital · 16d
Cleared Jan 27, 1984
SURG-A-STAT FINE TIP
K840374
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery
Cleared Jan 27, 1984
ADJUST-A-TEMP EXTRA FINE TIP
K840378
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery
Cleared Jan 26, 1984
RAYDEN MEDICAL MINI PULSE VOLUME RECORD
K833155 · DSB
Burditt & Calkins-Siemens-Elema
Cardiovascular · 133d
Cleared Jan 26, 1984
AMBULASE XAM-15 XANAR SURG. LASER
K833325
Xanar, Inc.
General & Plastic Surgery · 121d
Cleared Jan 26, 1984
ROTARY VASCULAR KNIFE
K833547 · DWS
Formedco, Inc.
Cardiovascular · 106d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE BARBITURATE
K833577 · DIS
Syva Co.
Toxicology · 106d