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
168577–168600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1979
MIRADAPT* DENTAL RESTORATIVE
K791318 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 62d
Cleared Sep 12, 1979
MIRADAPT* POLISHING INSTRUMENTS
K791319 · EJR
Johnson & Johnson Professionals, Inc.
Dental · 62d
Cleared Sep 12, 1979
JELCO & KVO CATHETER PLACEMENT UNIT
K791372 · JCY
Jelco Laboratories
General & Plastic Surgery · 50d
Cleared Sep 12, 1979
MODEL 484-01 BIPOLAR COAXIAL PACING LEAD
K791377 · DTB
Intermedics, Inc.
Cardiovascular · 50d
Cleared Sep 12, 1979
MODEL 482-01 BIPOLAR COAXIAL PACING LEAD
K791378 · DTB
Intermedics, Inc.
Cardiovascular · 50d
Cleared Sep 12, 1979
MODEL 228-02 THINLITH II PACEMAKER, BIPO
K791379 · DXY
Intermedics, Inc.
Cardiovascular · 50d
Cleared Sep 12, 1979
FLEXIFO ENTERAL NUTRITION PUMP
K791528 · FRN
Abbott Laboratories
General Hospital · 33d
Cleared Sep 12, 1979
FLEXIFLO ENTERAL PUMP SET
K791531 · BSS
Abbott Laboratories
Gastroenterology & Urology · 33d
Cleared Sep 12, 1979
TEMP-STIK MODEL #300
K791558 · FLL
Temp-Stik Corp.
General Hospital · 26d
Cleared Sep 12, 1979
MODIFIED TEMPA-DOT THERMOMETER
K791574 · FQZ
Info-Chem
General Hospital · 30d
Cleared Sep 12, 1979
TENS-O-TEST
K791637 · DXN
Curomatic, Inc.
Cardiovascular · 22d
Cleared Sep 12, 1979
MODEL E2510 SURGISWITCH
K791638 · GEI
Valleylab, Inc.
General & Plastic Surgery · 22d
Cleared Sep 12, 1979
MODEL E2515 ELECTROSURGICAL ACCESSORY
K791639 · GEI
Valleylab, Inc.
General & Plastic Surgery · 22d
Cleared Sep 12, 1979
BONE MARROW NEEDLE
K791643 · GDM
Johannah Medical Services, Inc.
General & Plastic Surgery · 20d
Cleared Sep 12, 1979
PREPACELL-BONE MARROW SAMPLER
K791660 · FMF
Applied Medical Devices, Inc.
General Hospital · 22d
Cleared Sep 12, 1979
CARDIOVASCULAR INSTRUMENTS-VARIOUS
K791710 · DWS
Edward Weck, Inc.
Cardiovascular · 16d
Cleared Sep 12, 1979
SURGICAL INSTRUMENTS HEIFETZ DIGITATE
K791734 · FZT
Edward Weck, Inc.
General & Plastic Surgery · 12d
Cleared Sep 07, 1979
URITRON URINE METER
K790894 · FFG
Joseph F. Daniel, C.R.N.A.
Gastroenterology & Urology · 122d
Cleared Sep 07, 1979
INSTANT HOT & COLD PACKS
K790993 · IMD
Chase Mfg. Co.
Physical Medicine · 101d
Cleared Sep 07, 1979
ANTIBODY TO HERPESVIRUS HOMINIS
K791058 · GQO
Electro-Nucleonics Laboratories, Inc.
Microbiology · 91d
Cleared Sep 07, 1979
CONPHAR FEMALE CATHETER-STERILE
K791244 · KOD
Conphar, Inc.
Gastroenterology & Urology · 63d
Cleared Sep 07, 1979
CONPHAR FEMALE CATHETER W/BAG-STERILE
K791252 · KNX
Conphar, Inc.
Gastroenterology & Urology · 63d
Cleared Sep 07, 1979
CONPHAR URINARY DRAINAGE BAG-2000ML
K791265 · KNX
Conphar, Inc.
Gastroenterology & Urology · 63d
Cleared Sep 07, 1979
TECHNION ELECTRONIC FEVER THERMOMETER
K791323 · FLL
Technicon Corp.
General Hospital · 52d